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☐ ☆ ✇ BMJ Open

Effect of extracorporeal shock wave combined with Kinesio taping on upper limb function during individuals with biceps brachii tendinopathy:protocol for a double-blind, randomised controlled trial

Por: Liu · K. · Yin · L. · Zhang · Y. · Huang · L. · Liu · G. · Zhu · R. · Fang · P. · Ma · Y. · Ma · Z. — Enero 8th 2024 at 17:52
Introduction

Long head of biceps brachii tendinopathy (LHBT) is characterised by persistent pain and disability of shoulder joint, impairing patients’ quality of life. Extracorporeal shock wave therapy (ESWT) is a non-invasive treatment, which promotes tissue regeneration and repair. However, ESWT has a side effect that often causes short-term pain and swelling in the treatment area. It is known that the effects of Kinesio taping (KT) on relieving swelling and pain. Due to insufficient clinical evidence from current limited studies, this randomised controlled study aims to explore the effects of ESWT combined with KT on upper limb function during individuals with LHBT.

Methods and analysis

A 2x2 factorial design, double-blind, randomised controlled trial will be conducted. A total of 144 participants will be randomly allocated into one of four groups (KT+ESWT, KT+sham ESWT, sham KT+ESWT or sham KT+sham ESWT) to participate in a 4-week treatment programme. Measurements will be taken at pretreatment (baseline), immediately after treatment and 6 weeks after treatment. The primary endpoint will be the Constant-Murley score (CMS), the secondary endpoints will include the pain Numerical Rating Scale, range of motion, pressure pain threshold and soft tissue hardness of biceps, speed test and global rating of change. Repeated measures analysis of variance will be used to compare differences among the effects of different interventions.

Ethics and dissemination

Ethics approval was obtained from the Ethics Committee of the Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. In addition to international conference reports, findings will be disseminated through international publications in peer-reviewed journals.

Trial registration number

ChiCTR2100051324.

☐ ☆ ✇ BMJ Open

Lipid-focused dietary education intervention in pregnant women: study protocol for an open-label, parallel, randomised, intervention study addressing adverse pregnancy outcomes in China

Por: Zhang · Y. · Gao · X. · Zhu · H. · Sun · S. · Contento · I. R. · Koch · P. A. · Yu · H. — Enero 4th 2024 at 17:13
Introduction

The incidence of infants who are large-for-gestational-age (LGA) is on the rise in China, and its detrimental effects on health have received increasing attention. Diet-based interventions have the potential to reduce adverse birth outcomes, particularly in decreasing the occurrence of LGA infants. We aim to evaluate the effect of lipid-focused diet education based on the theories of behaviour change in pregnant women on maternal and offspring outcomes through a randomised controlled trial.

Methods and analysis

We have designed an open-label, parallel, multicentre randomised controlled trial in collaboration with three hospitals in Beijing, China.

Pregnant women will be recruited before reaching 12 weeks of gestation and will be randomised in a 1:1:1 ratio into three arms: (1) online education arm, (2) pregnancy nutrition checklist and ‘one-page flyer’ arm and (3) routine antenatal education. The primary outcome LGA will be recorded at birth. Demographic information, physical activity, sleep and medical history will be collected through questionnaires and case cards prior to enrolment. Questionnaires will also be used to collect dietary behaviours and psychosocial factors of pregnant women at enrolment, at 24–28 weeks and 34–36 weeks of gestation. Additionally, information on breastfeeding and complementary food supplementation for infants and young children will be obtained through questionnaires. Physical development indicators of children and taste tests will be assessed 3 years after delivery.

Ethics and dissemination

The study has received ethical approval from the Capital Medical University Ethics Committee and other collaborating study centres. Informed consent will be introduced to pregnant women, and their consent will be obtained. The findings will be reported in relevant national and international academic conferences and peer-reviewed publications.

Trial registration number

ChiCTR2300071126.

☐ ☆ ✇ BMJ Open

Ultrasound-guided puncture drainage versus surgical incision drainage for deep neck space abscesses: a protocol for a systematic review with meta-analysis and trial sequential analysis

Por: Nie · W. · Du · L. · Chen · G. · Zheng · Y. · Yang · X. · Li · B. · Zhang · W. · Zheng · J. — Enero 4th 2024 at 17:13
Introduction

Deep neck space abscesses (DNAs) are serious surgical emergencies, associated with life-threatening complications. Surgical incision and drainage combined with antibiotics is the main treatment for DNAs, but drawbacks still exist. Ultrasound-guided puncture drainage is an alternative treatment for some DNAs with limited clinical evidence. Hence, the optimal drainage technique for the treatment of DNAs remains unclear. Therefore, we will perform a protocol for a systematic review and meta-analysis to identify the efficacy of ultrasound-guided puncture drainage for DNAs.

Methods and analysis

PubMed, Ovid Medline, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure, Wanfang database, VIP database and trial registry databases will be searched from inception to September 2023 to identify randomised controlled trials of patients diagnosed with DNAs accepting ultrasound-guided puncture drainage. The primary outcome will be the length of hospital stay. The secondary outcomes will be the cure rate, incidence of retreatment, complications and overall cost to the healthcare system. Fixed-effects or random-effects model will be used according to the statistical heterogeneity. Mean differences or standardised mean differences with 95% CIs for continuous data and risk ratio (RR) with 95% CIs for dichotomous data. The Cochrane risk-of-bias tool 2, Grading of Recommendations Assessment, Development and Evaluation (GRADE) and trial sequential analysis will be conducted to evaluate the evidence quality and control the random errors. Funnel plots and Egger’s regression test will be performed to evaluate publication bias.

Ethics and dissemination

Ethical approval was not required for this systematic review protocol. The results will be disseminated through peer-reviewed publications.

PROSPERO registration number

CRD42023441031.

☐ ☆ ✇ BMJ Open

Effectiveness of general anaesthesia with remimazolam tosilate on intraoperative haemodynamics and postoperative recovery: study protocol for a randomised, positive-controlled, pragmatic clinical trial (GARTH trial)

Por: Lu · C. · Kang · Y. · Luo · Q. · Zhong · F. · Cai · Y. · Zhang · G. · Guo · Z. · Zhang · S. · Ma · J. · Shu · H. — Enero 4th 2024 at 17:13
Introduction

It is encouraged to estimate the effectiveness of components within the enhanced recovery after surgery (ERAS) protocol through patient-reported outcomes, alongside doctor-reported outcomes and length of hospital stay. At present, studies on the contributions of optimal anaesthetic drugs within the ERAS protocol to patient-reported and doctor-reported outcomes are limited. Therefore, this study aims to pragmatically evaluate the effectiveness and safety of general anaesthesia (GA) with remimazolam tosilate within the ERAS protocol on intraoperative haemodynamics and postoperative recovery in adults undergoing elective surgeries, compared with propofol.

Methods and analysis

This study is a single-centre, randomised, blinded, positive-controlled, pragmatic clinical trial. A total of 900 patients, aged ≥18 years old, scheduled for an elective surgical procedure under GA will be included. Patients will be randomised in a 1:1 ratio to the remimazolam group (the GA with remimazolam tosilate within the ERAS protocol group) or propofol group (the GA with propofol within the ERAS protocol group), stratified by general surgery, thoracic surgery and other surgeries (including urological surgery and otolaryngology surgery). The primary outcomes include the 24-hour postoperative quality of recovery-40 score and the rate of intraoperative hypotension. Secondary endpoints include the rate of sedative hypotension requiring treatment, the haemodynamic profiles, the 72-hour postoperative quality of recovery-40 score, the functional anaesthetic capability, adverse events and complications, quality of life within 3 months as well as economic health outcomes.

Ethics and dissemination

This study protocol has been approved by the ethics committee of Guangdong Provincial People’s Hospital (KY-H-2022-005-03-08). Dissemination plans will be presented at scientific meetings and in scientific publications.

Trial registration number

ChiCTR2200062520

☐ ☆ ✇ BMJ Open

Incidence of community-acquired pneumonia among children under 5 years in Suzhou, China: a hospital-based cohort study

Por: Qian · C. · Chen · Q. · Lin · W. · Li · Z. · Zhu · J. · Zhang · J. · Luan · L. · Zheng · B. · Zhao · G. · Tian · J. · Zhang · T. — Enero 3rd 2024 at 17:10
Objectives

To depict the seasonality and age variations of community-acquired pneumonia (CAP) incidence in the context of the COVID-19 impact.

Design

Retrospective cohort study.

Participants

The observational cohort study was conducted at Soochow University Affiliated Children’s Hospital from January 2017 to June 2021 and involved 132 797 children born in 2017 or 2018. They were followed and identified CAP episodes by screening on the Health Information Systems of outpatients and inpatients in the same hospital.

Outcome

The CAP episodes were defined when the diagnoses coded as J09–J18 or J20–J22. The incidence of CAP was estimated stratified by age, sex, birth year, health status group, season and month, and the rate ratio was calculated and adjusted by a quasi-Poisson regression model. Stratified analysis of incidence of CAP by birth month was conducted to understand the age and seasonal variation.

Results

The overall incidence of CAP among children aged ≤5 years was 130.08 per 1000 person years. Children aged ≤24 months have a higher CAP incidence than those aged >24 months (176.84 vs 72.04 per 1000 person years, p

Conclusions

The burden of CAP among children is considerable. The incidence of CAP among children ≤5 years varied by age and season and decreased during COVID-19 lockdown.

☐ ☆ ✇ BMJ Open

Human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis (MSC-DLC-1): a dose-escalation, phase I trial protocol

Por: Wang · Z. · Li · T. · Zhang · Z. · Yuan · M. · Shi · M. · Wang · F.-S. · Linghu · E.-Q. · Shi · L. — Diciembre 30th 2023 at 13:21
Introduction

There are limited therapeutic options to efficiently treat patients with decompensated liver cirrhosis. This trial aims to explore the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (UC-MSCs) for the treatment of patients with decompensated liver cirrhosis.

Methods and analysis

This study is an open-label, dose-escalation, one-armed phase I trial. A single injection of UC-MSCs will be administered in a predetermined dose in each cohort (5.0x107, 1.0x108, 1.5x108 or 2.0x108 cells) according to the ‘3+3’ rule. The primary evaluation measures will include the incidence of adverse events and the change in the Model for End-stage Liver Disease (MELD) score from baseline to the 28th day. Secondary evaluation measures will be evaluated at baseline and at each follow-up point. These measures will include the change in the MELD score from baseline to each follow-up point, the incidence of each complication associated with decompensated cirrhosis, liver transplant-free survival and the incidence of liver failure, among other relevant measures. All patients will be followed up for 24 months. This study will evaluate whether the use of UC-MSCs to treat patients with decompensated liver cirrhosis is safe and tolerable.

Ethics and dissemination

The study has been approved by the Chinese People’s Liberation Army General Hospital (Approval#: 2018-107-D-4). Once conducted, the results from the study will be published in a peer-reviewed journal.

Trial registration number

NCT05227846.

☐ ☆ ✇ BMJ Open

Northern Shanghai Study II: systematic assessment and management of early organ damage and its role in preventing and reducing cardiovascular risk--protocol of a prospective study

Por: Hou · J. · Li · M. · Han · J. · Yu · S. · Jia · X. · Sun · F. · Zhang · Y. — Diciembre 30th 2023 at 13:21
Introduction

Cardiovascular diseases are the leading cause of death and disease burden in China. However, there is a lack of prospective cohort studies suitable for evaluating early organ damage and its role in preventing and reducing cardiovascular risk among Chinese residents. This study intends to establish the first database based on the phenotypes of all early structural and functional damage of cardiovascular organs in Chinese population. Moreover, a digital follow-up mechanism will be formed, a prospective population cohort will be established, a biological sample bank for early cardiovascular organ damage will be established, and an intervention and management system for early damage of cardiovascular organs will be explored.

Methods and analysis

This study is a prospective cohort study built on the foundation of the Northern Shanghai Study I. People aged 18–75 years are enrolled. After the recruitment, first, corresponding physical measurements and clinical examinations are conducted to collect cardiovascular risk factors and establish the demographic baseline of the study population. Next, the latest equipment is used to evaluate early structural and functional cardiovascular organ damage including heart, macrovessels, microcirculation, renal function and fundus. Meanwhile, the blood, urine, faeces and other biological samples of participants are collected to establish the cardiometabolic and gut microbiota analysis databases. The population is followed up every 2 years. Comprehensive assessment of early organ damage will be used to predict cardiovascular risk, guide people to change lifestyles to achieve early prevention and provide corresponding treatment recommendations.

Ethics and dissemination

This study was approved by the Shanghai Tenth People’s Hospital Institutional Review Board. All participants signed a written consent form. The results of this study will be disseminated in peer-reviewed journals. Ethics approval: SHYS-IEC-5.0/22k148/P01.

Trial registration number

NCT05435898.

☐ ☆ ✇ BMJ Open

Attitude of cardiac surgery nurses on kinesiophobia management: a qualitative study

Por: Wang · Y. · Chen · Y. · Zhang · X. · Liu · S. — Diciembre 30th 2023 at 13:21
Objectives

This study aimed to investigate the knowledge, attitudes and practical experiences of cardiac surgery nurses regarding kinesiophobia management during early mobilisation.

Design

Using a descriptive qualitative research method, 21 cardiac surgery nurses participated in this study from October 2022 to January 2023, and the interview data were analysed using the Colaizzi 7-step analysis method.

Setting

Data were collected through in-depth face-to-face or online interviews in a tertiary hospital located in Nanjing, China.

Participants

21 cardiac surgery nurses were interviewed from October 2022 to January 2023.

Results

Two themes were summarised: knowledge, attitude and practice of nurses (high recognition and low participation; low knowledge reserve; low willingness); the promotion and essential elements of kinesiophobia management (efficient health education model; stable medical staff–family caregiver collaboration; simplified clinical protocol; specialist nursing team; clarify the multidisciplinary division of labour).

Conclusion

The management of kinesiophobia in patients undergoing cardiac surgery is currently in the developmental phase. It is advisable to give due consideration to emotional support and cognitive training for medical staff. In addition, a workable management plan, consistent with clinical practice, should be formulated through multidisciplinary and medical staff–family caregiver collaboration to optimise patient outcomes.

☐ ☆ ✇ BMJ Open

Changing epidemiology, microbiology and mortality of bloodstream infections in patients with haematological malignancies before and during SARS-CoV-2 pandemic: a retrospective cohort study

Por: Cai · L. · Chen · H. · Wei · Y. · Guo · X. · Zheng · H. · Jiang · X. · Zhang · Y. · Yu · G. · Dai · M. · Ye · J. · Zhou · H. · Xu · D. · Huang · F. · Fan · Z. · Xu · N. · Shi · P. · Xuan · L. · Feng · R. · Liu · X. · Sun · J. · Liu · Q. · Wei · X. — Diciembre 30th 2023 at 13:21
Objective

This study was to explore the changes in bacterial bloodstream infection (BSI) in patients with haematological malignancies (HMs) before and during SARS-CoV-2 pandemic.

Design

Retrospective cohort study between 2018 and 2021.

Setting

The largest haematological centre in southern China.

Results

A total of 599 episodes of BSI occurring in 22 717 inpatients from January 2018 to December 2021 were analysed. The frequencies of the total, Gram-negative and Gram-positive BSI before and during the pandemic were 2.90% versus 2.35% (p=0.011), 2.49% versus 1.77% (p

Conclusion

Our data showed that the incidence of total and Gram-negative organisms BSI decreased, but Gram-positive BSI incidence increased in patients with HMs during the pandemic along with the changes of main isolates and susceptibility profiles. Although the 30-day mortality due to BSI was lower during the pandemic, the new infection prevention strategy should be considered for any future pandemics.

☐ ☆ ✇ BMJ Open

Trends in liver cancer mortality in China from 1990 to 2019: a systematic analysis based on the Global Burden of Disease Study 2019

Por: Chen · T. · Zhang · Y. · Liu · J. · Rao · Z. · Wang · M. · Shen · H. · Zeng · S. — Diciembre 30th 2023 at 13:21
Objective

We aimed to examine trends in overall mortality rates for liver cancer and those within subgroups according to sex, age, aetiological factors and modifiable risk factors in China from 1990 to 2019.

Design

The design of this study involved analysing liver cancer mortality rates in China from 1990 to 2019 using joinpoint regression analysis to identify significant changes in mortality rates. Annual percentage changes (APCs) and 95% CIs were used to quantify the magnitude of changes in mortality rates. The study also conducted subgroup analyses based on sex, age, aetiological factors and risk factors to better understand trends in liver cancer mortality rates.

Results

The age-standardised mortality from liver cancer in China first increased from 28.12 to 31.54 deaths per 100 000 population in 1990–1996 (APC=2.1%, 95% CI: 1.5% to 2.6%), then dropped at varying rates (1996–2000, APC=–3.7%, 95% CI: –5.2% to –2.1%; 2000–2004, APC=–17.4%, 95% CI: –18.7% to –16.1%; 2004–2007, APC=–5.4%, 95% CI: –8.3% to –2.3%; and 2007–2012, APC=–1.4%, 95% CI: –2.3% to –0.4%), and began to increase again after 2012 (APC=1.3%, 95% CI: 0.9% to 1.7%). Hepatitis B and C virus infections accounted for 63% and 18% of liver cancer-related deaths, respectively, in China from 1990 to 2019. Smoking, drug use, alcohol use and elevated body mass index were the four leading risk factors for liver cancer mortality in China during the study period. Notable variations in both liver cancer mortality rates and changes in mortality rates were observed across sexes and age groups.

Conclusions

The age-standardised liver cancer mortality rate in China significantly decreased from 1996 to 2019. The major differences in liver cancer mortality rates and inconsistent changes in mortality rates between 1990 and 2019 merit the attention of researchers and policymakers.

☐ ☆ ✇ BMJ Open

Hypertension, socioeconomic status and depressive and anxiety disorders: a cross-sectional study of middle-aged and older Chinese women

Por: Wang · X. · Gao · D. · Wang · X. · Zhang · X. · Song · B. — Diciembre 28th 2023 at 16:47
Objectives

To investigate the association of hypertension with depressive and anxiety disorders in middle-aged and older Chinese women, and to further assess whether the association was influenced by socioeconomic status (SES).

Design

Nationwide cross-sectional study.

Setting

Six provinces of the eastern, central and western regions of China.

Participants

Women aged 40–70 years were included by a multistage stratified random cluster sampling in 2018 (N=9900).

Primary outcome measures

Depressive and anxiety disorders were measured by the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7, respectively. Logistic regression models were used to evaluate the OR and 95% CI for hypertension and the odds of depressive and anxiety disorders.

Results

18.5% of participants reported having hypertension; 20.9% and 15.3% of women experienced depressive and anxiety disorders, respectively. After adjusting for potential confounders, women diagnosed with hypertension were more likely to have depressive (OR=1.27, 95% CI 1.11 to 1.45) and anxiety disorders (OR=1.48, 95% CI 1.28 to 1.71) than those without hypertension. Stratified analyses demonstrated that hypertension was significantly associated with higher odds of depressive disorders in women living in rural areas (OR=1.34, 95% CI 1.13 to 1.59), with lower levels of education (OR=1.28, 95% CI 1.12 to 1.46) and with average monthly household income

Conclusions

Hypertension was associated with increased odds of depressive and anxiety disorders among middle-aged and older women, especially in those with low SES. Effective strategies and actions for identification and management of hypertension and depressive and anxiety disorders are needed.

☐ ☆ ✇ BMJ Open

Development and validation of a model to predict mortality risk among extremely preterm infants during the early postnatal period: a multicentre prospective cohort study

Por: Zhang · W.-w. · Wang · S. · Li · Y. · Dong · X. · Zhao · L. · Li · Z. · Liu · Q. · Liu · M. · Zhang · F. · Yao · G. · Zhang · J. · Liu · X. · Liu · G. · Zhang · X. · Reddy · S. · Yu · Y.-h. — Diciembre 28th 2023 at 16:47
Background

Recently, with the rapid development of the perinatal medical system and related life-saving techniques, both the short-term and long-term prognoses of extremely preterm infants (EPIs) have improved significantly. In rapidly industrialising countries like China, the survival rates of EPIs have notably increased due to the swift socioeconomic development. However, there is still a reasonably lower positive response towards the treatment of EPIs than we expected, and the current situation of withdrawing care is an urgent task for perinatal medical practitioners.

Objective

To develop and validate a model that is practicable for EPIs as soon as possible after birth by regression analysis, to assess the risk of mortality and chance of survival.

Methods

This multicentre prospective cohort study used datasets from the Sino-Northern Neonatal Network, including 46 neonatal intensive care units (NICUs). Risk factors including maternal and neonatal variables were collected within 1 hour post-childbirth. The training set consisted of data from 41 NICUs located within the Shandong Province of China, while the validation set included data from 5 NICUs outside Shandong Province. A total of 1363 neonates were included in the study.

Results

Gestational age, birth weight, pH and lactic acid in blood gas analysis within the first hour of birth, moderate-to-severe hypothermia on admission and adequate antenatal corticosteroids were influencing factors for EPIs’ mortality with important predictive ability. The area under the curve values for internal validation of our prediction model and Clinical Risk Index for Babies-II scores were 0.81 and 0.76, and for external validation, 0.80 and 0.51, respectively. Moreover, the Hosmer-Lemeshow test showed that our model has a constant degree of calibration.

Conclusions

There was good predictive accuracy for mortality of EPIs based on influencing factors prenatally and within 1 hour after delivery. Predicting the risk of mortality of EPIs as soon as possible after birth can effectively guide parents to be proactive in treating more EPIs with life-saving value.

Trial registration number

ChiCTR1900025234.

☐ ☆ ✇ BMJ 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. — Diciembre 22nd 2023 at 17:32
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.

☐ ☆ ✇ BMJ Open

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. — Diciembre 22nd 2023 at 04:36
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.

☐ ☆ ✇ BMJ Open

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. — Diciembre 22nd 2023 at 04:36
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).

☐ ☆ ✇ BMJ Open

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. — Diciembre 22nd 2023 at 04:36
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.

☐ ☆ ✇ BMJ Open

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. — Diciembre 22nd 2023 at 04:36
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.

☐ ☆ ✇ BMJ Open

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. — Diciembre 19th 2023 at 16:46
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.

☐ ☆ ✇ BMJ Open

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. — Diciembre 15th 2023 at 06:39
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.

☐ ☆ ✇ BMJ Open

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. — Diciembre 15th 2023 at 06:39
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.

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