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☐ ☆ ✇ BMJ Open

Exploratory study of using Magnetic resonance Prognostic Imaging markers for Radiotherapy In Cervix cancer (EMPIRIC): a prospective cohort study protocol

Por: Abdul-Latif · M. · Chowdhury · A. · Tharmalingam · H. · Taylor · N. J. · Lakhani · A. · Padhani · A. · Hoskin · P. · Tsang · Y. — Abril 18th 2024 at 17:47
Introduction

Radical chemoradiotherapy represents the gold standard for locally advanced cervical cancer. However, despite significant progress in improving local tumour control, distant relapse continues to impact overall survival. The development of predictive and prognostic biomarkers is consequently important to risk-stratify patients and identify populations at higher risk of poorer treatment response and survival outcomes. Exploratory study of using Magnetic resonance Prognostic Imaging markers for Radiotherapy In Cervix cancer (EMPIRIC) is a prospective exploratory cohort study, which aims to investigate the role of multiparametric functional MRI (fMRI) using diffusion-weighed imaging (DWI), dynamic contrast-enhanced (DCE) and blood oxygen level-dependent imaging (BOLD) MRI to assess treatment response and predict outcomes in patients undergoing radical chemoradiotherapy for cervical cancer.

Methods and analysis

The study aims to recruit 40 patients across a single-centre over 2 years. Patients undergo multiparametric fMRI (DWI, DCE and BOLD-MRI) at three time points: before, during and at the completion of external beam radiotherapy. Tissue and liquid biopsies are collected at diagnosis and post-treatment to identify potential biomarker correlates against fMRI. The primary outcome is to evaluate sensitivity and specificity of quantitative parameters derived from fMRI as predictors of progression-free survival at 2 years following radical chemoradiotherapy for cervical cancer. The secondary outcome is to investigate the roles of fMRI as predictors of overall survival at 2 years and tumour volume reduction across treatment. Statistical analyses using regression models and survival analyses are employed to evaluate the relationships between the derived parameters, treatment response and clinical outcomes.

Ethics and dissemination

The EMPIRIC study received ethical approval from the NHS Health Research Authority (HRA) on 14 February 2022 (protocol number RD2021-29). Confidentiality and data protection measures are strictly adhered to throughout the study. The findings of this study will be disseminated through peer-reviewed publications and scientific conferences, aiming to contribute to the growing body of evidence on the use of multiparametric MRI in cervical cancer management.

Trial registration number

NCT05532930.

☐ ☆ ✇ BMJ Open

Effects of different exercise interventions on chemotherapy-related cognitive impairment in patients with breast cancer: a study protocol for systematic review and network meta-analysis

Por: Dong · Y. · Huang · H. · Wang · A. — Abril 17th 2024 at 17:18
Introduction

Breast cancer stands as the most prevalent type of cancer affecting women globally, and chemotherapy plays a pivotal role in its treatment by diminishing tumour recurrence and enhancing the survival rates of patients. However, chemotherapy-related cognitive impairment (CRCI) often occurs in patients undergoing treatment. Although multiple clinical trials have indicated that exercise therapy can improve CRCI in patients with breast cancer, there are variations in the types of exercise interventions and their effectiveness. We aim to perform a pioneering network meta-analysis (NMA) to assess and prioritise the effectiveness of various exercise interventions in enhancing cognitive function in patients with breast cancer undergoing chemotherapy.

Methods and analysis

We will search multiple databases, including PubMed, Web of Science, Cochrane, Embase, China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, Wanfang and Sinomed databases, from their inception to May 2023. The main outcome is the cognitive function changes in patients with breast cancer, including subjective and objective results. We will specifically include randomised controlled trials reported in English and Chinese languages, whose primary outcome consists of an assessment of the cognitive function of patients with breast cancer using standardised and validated assessment tools, encompassing both subjective and objective outcomes. The quality of all the trials included will be evaluated based on ‘Version 2 of the Cochrane tool for assessing the risk of bias in randomized controlled trials (RoB2)’. We will conduct a Bayesian NMA to thoroughly evaluate and compare the effectiveness of different exercise interventions. We will use cumulative ranking probability plots to estimate the ranking of the best interventions for various exercises. Network plots and funnel plots will be employed to display the study sizes and participants of each exercise intervention, as well as potential publication biases.

Ethics and dissemination

The study findings will be shared via peer-reviewed journals to ensure the highest quality and credibility of the research. As the reporting will not include any private patient data, there are no ethical considerations associated with this protocol.

PROSPERO registration number

CRD42023406597.

☐ ☆ ✇ BMJ Open

Building CapaCITY/E for sustainable transportation: protocol for an implementation science research program in healthy cities

Por: Winters · M. · Fuller · D. · Cloutier · M.-S. · Harris · M. A. · Howard · A. · Kestens · Y. · Kirk · S. · Macpherson · A. · Moore · S. · Rothman · L. · Shareck · M. · Tomasone · J. R. · Laberee · K. · Stephens · Z. P. · Sones · M. · Ayton · D. · Batomen · B. · Bell · S. · Collins · P. · Diab — Abril 17th 2024 at 17:18
Introduction

Improving sustainable transportation options will help cities tackle growing challenges related to population health, congestion, climate change and inequity. Interventions supporting active transportation face many practical and political hurdles. Implementation science aims to understand how interventions or policies arise, how they can be translated to new contexts or scales and who benefits. Sustainable transportation interventions are complex, and existing implementation science frameworks may not be suitable. To apply and adapt implementation science for healthy cities, we have launched our mixed-methods research programme, CapaCITY/É. We aim to understand how, why and for whom sustainable transportation interventions are successful and when they are not.

Methods and analysis

Across nine Canadian municipalities and the State of Victoria (Australia), our research will focus on two types of sustainable transportation interventions: all ages and abilities bicycle networks and motor vehicle speed management interventions. We will (1) document the implementation process and outcomes of both types of sustainable transportation interventions; (2) examine equity, health and mobility impacts of these interventions; (3) advance implementation science by developing a novel sustainable transportation implementation science framework and (4) develop tools for scaling up and scaling out sustainable transportation interventions. Training activities will develop interdisciplinary scholars and practitioners able to work at the nexus of academia and sustainable cities.

Ethics and dissemination

This study received approval from the Simon Fraser University Office of Ethics Research (H22-03469). A Knowledge Mobilization Hub will coordinate dissemination of findings via a website; presentations to academic, community organisations and practitioner audiences; and through peer-reviewed articles.

☐ ☆ ✇ BMJ Open

Aspirin versus metformin in pregnancies at high risk of preterm pre-eclampsia in China (AVERT): protocol for a multicentre, double-blind, 3-arm randomised controlled trial

Por: Liu · J. · Shen · L. · Nguyen-Hoang · L. · Zhou · Q. · Wang · C. C. · Lu · X. · Sahota · D. · Chong · K. C. · Ying · H. · Gu · W. · Zhou · R. · Yang · H. · Jiang · Y. · Chen · D. · Li · X. · Poon · L. — Abril 17th 2024 at 17:18
Introduction

Pre-eclampsia (PE) affects about 5% of Chinese pregnant women and is a major cause of maternal and perinatal morbidity and mortality. The first trimester screening model developed by the Fetal Medicine Foundation, which uses the Bayes theorem to combine maternal characteristics and medical history together with measurements of biomarkers, has been proven to be effective and has superior screening performance to that of the traditional risk factor-based approach for the prediction of PE. Prophylactic use of low-dose aspirin in women at risk for PE has resulted in a lower incidence of preterm-PE. However, there is no consensus on the preferred aspirin dosage for the prevention of preterm-PE. Evidence has also suggested that metformin has the potential benefit in preventing PE in pregnant women who are at high risk of the disorder.

Method and analysis

We present a protocol (V.2.0, date 17 March 2022) for the AVERT trial, which is a multicentre, double-blinded, 3-arm randomised controlled trial (RCT) that uses an effective PE screening programme to explore the optimal dosage of aspirin and the role of metformin for the prevention of PE among high-risk pregnant women in China. We intend to recruit 66 000 singleton pregnancies without treatment of low-dose aspirin and metformin at 11–13 weeks’ gestation and all eligible women attending for their first trimester routine scan will be invited to undergo screening for preterm-PE by the combination of maternal factors, mean arterial pressure and placental growth factor. Women found to be at high risk of developing preterm-PE will be invited to take part in the RCT. This study will compare the incidence of preterm-PE with delivery at

Ethics and dissemination

Ethical approval for the study was obtained from the Joint Chinese University of Hong Kong–New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No. 2021.406) in Hong Kong and the Ethics Committee of each participating hospital in Mainland China. The study is registered at ClinicalTrials.gov. The results of the AVERT trial will be disseminated at international academic conferences and published in high-impact factor journals.

Trial registration number

NCT05580523.

☐ ☆ ✇ BMJ Open

Colchicine for the treatment of patients with COVID-19: an updated systematic review and meta-analysis of randomised controlled trials

Por: Cheema · H. A. · Jafar · U. · Shahid · A. · Masood · W. · Usman · M. · Hermis · A. H. · Naseem · M. A. · Sahra · S. · Sah · R. · Lee · K. Y. — Abril 17th 2024 at 17:18
Objectives

We conducted an updated systematic review and meta-analysis to investigate the effect of colchicine treatment on clinical outcomes in patients with COVID-19.

Design

Systematic review and meta-analysis.

Data sources

We searched PubMed, Embase, the Cochrane Library, medRxiv and ClinicalTrials.gov from inception to January 2023.

Eligibility criteria

All randomised controlled trials (RCTs) that investigated the efficacy of colchicine treatment in patients with COVID-19 as compared with placebo or standard of care were included. There were no language restrictions. Studies that used colchicine prophylactically were excluded.

Data extraction and synthesis

We extracted all information relating to the study characteristics, such as author names, location, study population, details of intervention and comparator groups, and our outcomes of interest. We conducted our meta-analysis by using RevMan V.5.4 with risk ratio (RR) and mean difference as the effect measures.

Results

We included 23 RCTs (28 249 participants) in this systematic review. Colchicine did not decrease the risk of mortality (RR 0.99; 95% CI 0.93 to 1.05; I2=0%; 20 RCTs, 25 824 participants), with the results being consistent among both hospitalised and non-hospitalised patients. There were no significant differences between the colchicine and control groups in other relevant clinical outcomes, including the incidence of mechanical ventilation (RR 0.75; 95% CI 0.48 to 1.18; p=0.22; I2=40%; 8 RCTs, 13 262 participants), intensive care unit admission (RR 0.77; 95% CI 0.49 to 1.22; p=0.27; I2=0%; 6 RCTs, 961 participants) and hospital admission (RR 0.74; 95% CI 0.48 to 1.16; p=0.19; I2=70%; 3 RCTs, 8572 participants).

Conclusions

The results of this meta-analysis do not support the use of colchicine as a treatment for reducing the risk of mortality or improving other relevant clinical outcomes in patients with COVID-19. However, RCTs investigating early treatment with colchicine (within 5 days of symptom onset or in patients with early-stage disease) are needed to fully elucidate the potential benefits of colchicine in this patient population.

PROSPERO registration number

CRD42022369850.

☐ ☆ ✇ BMJ Open

Linking genetic counseling communication skills to patient outcomes and experiences using a community-engagement and provider-engagement approach: research protocol for the GC-PRO mixed methods sequential explanatory study

Por: Fisher · E. R. · Cragun · D. · Dedrick · R. F. · Lumpkins · C. Y. · Ramirez · M. · Kaphingst · K. A. · Petersen · A. · MacFarlane · I. M. · Redlinger-Grosse · K. · Shire · A. · Culhane-Pera · K. A. · Zierhut · H. A. — Abril 17th 2024 at 17:18
Introduction

In over 50 years since the genetic counseling (GC) profession began, a systematic study of GC communication skills and patient-reported outcomes in actual sessions across multiple clinical specialties has never been conducted. To optimize GC quality and improve efficiency of care, the field must first be able to comprehensively measure GC skills and determine which skills are most critical to achieving positive patient experiences and outcomes. This study aims to characterise GC communication skills using a novel and pragmatic measure and link variations in communication skills to patient-reported outcomes, across clinical specialties and with patients from diverse backgrounds in the USA. Our community-engagement and provider-engagement approach is crucial to develop recommendations for quality, culturally informed GC care, which are greatly needed to improve GC practice.

Methods and analysis

A mixed methods, sequential explanatory design will be used to collect and analyze: audio-recorded GC sessions in cancer, cardiac, and prenatal/reproductive genetic indications; pre-visit and post-visit quantitative surveys capturing patient experiences and outcomes and post-visit qualitative interview data. A novel, practical checklist will measure GC communication skills. Coincidence analysis will identify patterns of GC skills that are consistent with high scores on patient-reported measures. Two-level, multilevel models will be used to evaluate how GC communication skills and other session/patient characteristics predict patient-reported outcomes. Four community advisory boards (CABs) and a genetic counselor advisory board will inform the study design and analysis.

Ethics and dissemination

This study has been approved by the single Institutional Review Board of the University of Minnesota. This research poses no greater than minimal risk to participants. Results from this study will be shared through national and international conferences and through community-based dissemination as guided by the study’s CABs. A lay summary will also be disseminated to all participants.

☐ ☆ ✇ BMJ Open

Randomised controlled, patient-blinded, multicentre, superiority trial to evaluate the efficacy of the line-attached sheath-type traction device for endoscopic submucosal dissection in patients with superficial gastric neoplasms

Por: Abe · H. · Sako · T. · Yamamoto · Y. · Ikeda · A. · Kawara · F. · Ose · T. · Takao · T. · Kitamura · Y. · Ariyoshi · R. · Morita · Y. · Ishida · T. · Ikegawa · T. · Ishida · R. · Yoshizaki · T. · Sakaguchi · H. · Toyonaga · T. · Kodama · Y. — Abril 17th 2024 at 17:18
Introduction

EndoTrac is a line-attached sheath-type traction device that enables us to control the direction and the force of traction during endoscopic submucosal dissection (ESD). The efficacy of EndoTrac for gastric ESD has not been fully verified.

Methods and analysis

The G-Trac study is a multicentre (nine general hospitals and two university hospitals in Japan) collaborative trial assessing the efficacy of EndoTrac for gastric ESDs. Patients with superficial gastric neoplasms will be enrolled and randomly assigned to undergo either conventional ESD or EndoTrac ESD. Allocation will be stratified according to tumour location, operator experience and tumour diameter at an allocation rate of 1:1. The type of endoknife used will be confirmed before randomisation. The primary outcome, procedure time, will be compared between the groups in both intention-to-treat and per-protocol analyses using the Wilcoxon rank sum test. The efficacy-related, safety-related and device-related outcomes will be assessed in the secondary analysis. The planned sample size of the 142 patients in the two groups will enable us to detect a difference with a power of 80% by using the Wilcoxon rank sum test, assuming an effect size of 0.54, asymptotic relative efficiency of 0.864 and a two-sided type 1 error rate of 5%.

Ethics and dissemination

This trial was approved by the certified review board of Kobe University (22 December 2022). The results from this trial will be disseminated through peer-review journals, presentations at national and international conferences, and data sharing with other researchers.

Trial registration number

jRCT1052220166.

☐ ☆ ✇ BMJ Open

Skin closUre in carPal tunnEl Release (SUPER): protocol for a blinded randomised controlled trial comparing absorbable and non-absorbable sutures in carpal tunnel release

Por: Savolainen · A. · Nietosvaara · Y. · Sirola · J. · Hytönen · M. · Reito · A. · Heikkinen · N. · Räisänen · M. P. — Abril 16th 2024 at 18:01
Introduction

Carpal tunnel syndrome is a common disorder affecting a substantial portion of the general population. Surgical intervention is often deemed necessary, with the median nerve release being one of the most frequent operations. Optimising all the aspects of this procedure can enhance patient satisfaction with the treatment.

Methods and analysis

We aim to determine the differences in the aesthetic outcome of the scar as well as the pain experienced during the healing process between the use of absorbable and non-absorbable sutures. The primary outcome measure will be the patients’ subjective satisfaction with the aesthetic appearance of the scar 1 year after the operation. Secondary outcomes will include a similar evaluation of the aesthetics performed by a blinded outcome assessor, as well as pain experienced by the patients during the 2 weeks postoperatively. The severity and improvement of the patients’ symptoms will also be measured by a Finnish version of the Boston Carpal Tunnel Questionnaire. Costs will be evaluated for both groups. Safety of the wound closure will be followed and reported.

Ethics and dissemination

This protocol was approved by the Research Ethics Committee of the Northern Savo Hospital District (2319/2021). The trial will be conducted in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki. The results will be disseminated through publication in peer-reviewed journals.

Trial registration number

NCT05503719.

☐ ☆ ✇ BMJ Open

Missed nursing care and its associated factors in public hospitals of Bahir Dar City, Northwest Ethiopia: a cross-sectional study

Por: Abere · Y. · Biresaw · H. · Misganaw · M. · Netsere · B. · Adal · O. — Abril 16th 2024 at 18:01
Objectives

The aim of this study was to investigate the prevalence of missed nursing care and its associated factors among public hospitals in Bahir Dar City, Northwest Ethiopia.

Design

An institution-based cross-sectional study was conducted among 369 randomly selected nurses.

Setting

The study was conducted in primary and secondary-level public hospitals in Bahir Dar City.

Participants

Nurses who had worked in hospitals in Bahir Dar City were included.

Intervention

No intervention was needed in this study.

Primary and secondary outcome measures

A binary logistic regression model was used for statistical analysis. Statistical significance of the association between outcome variables and independent variables was declared at a p value of

Results

The prevalence of missed nursing care in this study was 46.3% (95% CI: 41.7% to 50.9%). The activities most frequently missed were physical examination (56.4%), patient discharge planning and teaching (50.9%), providing emotional support to the patient and family (50.8%), monitoring input and output (50.2%), assisting with patient ambulation (48.5%) and documentation (48%). Factors associated with missed nursing care include: male professionals (adjusted OR (AOR): 2.9, 95% CI: 1.8 to 4.8), those who had not received on-the-job training (AOR: 2.2, 95% CI: 1.4 to 3.6), those who worked full 24-hour shifts (AOR: 3.7, 95% CI: 2.0 to 6.5), those who were dissatisfied with the level of teamwork (AOR: 4.6, 95% CI: 2.8 to 7.6) and those who had an intention to leave the nursing profession (AOR: 1.8, 95% CI: 1.1 to 2.9). These factors were statistically associated with missed nursing care.

Conclusion

A significant proportion of nurses missed essential nursing care activities. Efforts should be made to enhance training, improve teamwork among nurses, provide stability and adjust work shifts to mitigate this issue.

☐ ☆ ✇ BMJ Open

Multicentre double-blind randomised placebo-controlled trial evaluating the efficacy of the meningococcal B vaccine, 4CMenB (Bexsero), against Neisseria gonorrhoeae infection in men who have sex with men: the GoGoVax study protocol

Por: Seib · K. L. · Donovan · B. · Thng · C. · Lewis · D. A. · McNulty · A. · Fairley · C. K. · Yeung · B. · Jin · F. · Fraser · D. · Bavinton · B. R. · Law · M. · Chen · M. Y. · Chow · E. P. F. · Whiley · D. M. · Mackie · B. · Jennings · M. P. · Jennison · A. V. · Lahra · M. M. · Grulich · A. E — Abril 16th 2024 at 18:01
Introduction

Gonorrhoea, the sexually transmissible infection caused by Neisseria gonorrhoeae, has a substantial impact on sexual and reproductive health globally with an estimated 82 million new infections each year worldwide. N. gonorrhoeae antimicrobial resistance continues to escalate, and disease control is largely reliant on effective therapy as there is no proven effective gonococcal vaccine available. However, there is increasing evidence from observational cohort studies that the serogroup B meningococcal vaccine four-component meningitis B vaccine (4CMenB) (Bexsero), licensed to prevent invasive disease caused by Neisseria meningitidis, may provide cross-protection against the closely related bacterium N. gonorrhoeae. This study will evaluate the efficacy of 4CMenB against N. gonorrhoeae infection in men (cis and trans), transwomen and non-binary people who have sex with men (hereafter referred to as GBM+).

Methods and analysis

This is a double-blind, randomised placebo-controlled trial in GBM+, either HIV-negative on pre-exposure prophylaxis against HIV or living with HIV (CD4 count >350 cells/mm3), who have had a diagnosis of gonorrhoea or infectious syphilis in the last 18 months (a key characteristic associated with a high risk of N. gonorrhoeae infection). Participants are randomised 1:1 to receive two doses of 4CMenB or placebo 3 months apart. Participants have 3-monthly visits over 24 months, which include testing for N. gonorrhoeae and other sexually transmissible infections, collection of demographics, sexual behaviour risks and antibiotic use, and collection of research samples for analysis of N. gonorrhoeae-specific systemic and mucosal immune responses. The primary outcome is the incidence of the first episode of N. gonorrhoeae infection, as determined by nucleic acid amplification tests, post month 4. Additional outcomes consider the incidence of symptomatic or asymptomatic N. gonorrhoeae infection at different anatomical sites (ie, urogenital, anorectum or oropharynx), incidence by N. gonorrhoeae genotype and antimicrobial resistance phenotype, and level and functional activity of N. gonorrhoeae-specific antibodies.

Ethics and dissemination

Ethical approval was obtained from the St Vincent’s Hospital Human Research Ethics Committee, St Vincent’s Hospital Sydney, NSW, Australia (ref: 2020/ETH01084). Results will be disseminated in peer-reviewed journals and via presentation at national and international conferences.

Trial registration number

NCT04415424.

☐ ☆ ✇ BMJ Open

Rationale and protocol for a prospective cohort study of respiratory viral infections in patients admitted from emergency departments of community hospitals: Effect of respiratory Virus infection on EmeRgencY admission (EVERY) study

Por: Morimoto · T. · Morikawa · T. · Imura · H. · Nezu · M. · Hamazaki · K. · Sakuma · M. · Chaumont · A. · Moitinho de Almeida · M. · Moreno · V. P. · Ho · Y. · Harrington · L. · Matsuki · T. · Nakamura · T. — Abril 16th 2024 at 08:27
Introduction

Respiratory syncytial virus (RSV) is a causative virus for the common cold worldwide and can result in hospitalisations and even death in patients with high-risk conditions and older adults. However, the relationship between RSV or other incidental respiratory infections and acute exacerbations of underlying conditions has not been well investigated. The primary objective of this study is to estimate RSV prevalence, risk factors for adverse outcomes or hospitalisation and their effect on the hospital course of patients with acute respiratory symptoms admitted from emergency departments. Furthermore, we evaluate the prevalence of other respiratory viruses associated with respiratory symptoms.

Methods and analysis

We are conducting a multicentre prospective cohort study in Japan. We plan to enrol 3000 consecutive patients admitted from emergency departments with acute respiratory symptoms or signs from 1 July 2023 to 30 June 2024. A nasopharyngeal swab is obtained within 24 hours of admission and the prevalence of RSV and other respiratory viruses is measured using the FilmArray Respiratory 2.1 panel. Paired serum samples are collected from patients with suspected lower respiratory infections to measure RSV antibodies at admission and 30 days later. Information on patients’ hospital course is retrieved from the electronic medical records at discharge, death or 30 days after admission. Furthermore, information on readmission to the hospital and all-cause mortality is collected 180 days after admission. We assess the differences in clinical outcomes between patients with RSV or other respiratory viruses and those without, adjusting for baseline characteristics. Clinical outcomes include in-hospital mortality, length of hospital stay, disease progression, laboratory tests and management of respiratory symptoms or underlying conditions.

Ethics and dissemination

The study protocol was approved by the institutional review boards of participating hospitals. Our study reports will be published in academic journals as well as international meetings.

Trial registration number

NCT05913700.

☐ ☆ ✇ BMJ Open

Cardiovascular safety of evogliptin dual and triple therapy in patients with type 2 diabetes: a nationwide cohort study

Por: Park · S. · Jeong · H. E. · Oh · I.-S. · Hong · S. · Yu · S. H. · Lee · C. B. · Shin · J.-Y. — Abril 16th 2024 at 08:27
Objective

To investigate the risk of cardiovascular events associated with commonly used dual and triple therapies of evogliptin, a recently introduced dipeptidyl peptidase-4 inhibitor (DPP4i), for managing type 2 diabetes in routine clinical practice.

Design

A retrospective cohort study.

Setting

Korean Health Insurance Review and Assessment database.

Participants

Patients who initiated metformin-based dual therapy and metformin+sulfonylurea-based triple therapy in South Korea from 2014 to 2018.

Interventions

Initiation of combination therapy with evogliptin.

Primary and secondary outcome measures

Hazards of cardiovascular events, a composite endpoint of myocardial infarction, heart failure and cerebrovascular events, and its individual components. Cox proportional hazards model with propensity score-based inverse probability of treatment weighting were used to estimate HRs and 95% CIs.

Results

From the dual and triple therapy cohorts, 5830 metformin+evogliptin users and 2198 metformin+sulfonylurea+evogliptin users were identified, respectively. Metformin+evogliptin users, as compared with metformin+non-DPP4i, had a 29% reduced risk of cardiovascular events (HR 0.71, 95% CI 0.62 to 0.82); HRs for individual outcomes were cerebrovascular events (0.71, 95% CI 0.53 to 0.95), heart failure (0.70, 95% CI 0.59 to 0.82), myocardial infarction (0.89, 95% CI 0.60 to 1.31). Metformin+sulfonylurea+evogliptin users, compared with metformin+sulfonylurea+non-DPP4i, had a 24% reduced risk of cardiovascular events (0.76, 95% CI 0.59 to 0.97); HRs for individual outcomes were myocardial infarction (0.57, 95% CI 0.27 to 1.19), heart failure (0.74, 95% CI 0.55 to 1.01), cerebrovascular events (0.96, 95% CI 0.61 to 1.51).

Conclusions

These findings suggest that dual or triple therapies of evogliptin for the management of type 2 diabetes in routine clinical practice present no cardiovascular harms, but could alternatively offer cardiovascular benefits in this patient population.

☐ ☆ ✇ BMJ Open

Effects of a therapeutic lifestyle modification intervention on cardiometabolic health, sexual functioning and health-related quality of life in perimenopausal Chinese women: protocol for a randomised controlled trial

Por: Wang · Y. · Miao · X. · Viwattanakulvanid · P. — Abril 16th 2024 at 08:27
Introduction

Perimenopause is a critical transitional period in reproductive ageing. A set of physiological and psychological changes can affect perimenopausal women’s quality of life and further threaten their older adult health conditions. In China, less than one-third of midlife women with menopausal symptoms have actively sought professional healthcare. Regarding the public health significance of comprehensive menopause management, the current study aims to investigate the effects of a therapeutic lifestyle modification (TLM) intervention on cardiometabolic health, sexual functioning and health-related quality of life among perimenopausal Chinese women.

Method and analysis

A randomised controlled trial with two parallel arms will be conducted at the gynaecology outpatient department of Yunnan Provincial Hospital of Traditional Chinese Medicine in China. 94 eligible perimenopausal women aged between 40 and 55 years will be recruited for the study. The TLM intervention consists of four elements: menopause-related health education, dietary guidance, pelvic floor muscle training and Bafa Wubu Tai Chi exercise. Participants will be randomly assigned (1:1) to receive either the 12-week TLM intervention or routine care via stratified blocked randomisation. The primary outcome is quality of life; secondary outcomes of interest include sexual functioning and cardiometabolic health. The outcome measures will be assessed at baseline and post-intervention. To explore the effects of the intervention, linear mixed models will be applied to test the changes between the two groups over time in each outcome based on an intention-to-treat analysis.

Ethics and dissemination

The Research Ethics Review Committee of Chulalongkorn University (COA No 178/66) and the Medical Ethics Committee of Yunnan Provincial Hospital of Traditional Chinese Medicine (IRB-AF-027-2022/02-02) approved the study protocol. Written informed consent will be obtained from all participants. Results will be published in peer-reviewed journals and disseminated through conferences.

Trial registration number

ChiCTR2300070648.

☐ ☆ ✇ BMJ Open

The N-LVA Study: effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) for patients with cancer who suffer from chronic peripheral lymphoedema - study protocol of a multicentre, randomised sham-controlled trial

Por: Kleeven · A. · Jonis · Y. M. J. · Tielemans · H. · van Kuijk · S. · Kimman · M. · van der Hulst · R. · Vasilic · D. · Hummelink · S. · Qiu · S. S. — Abril 16th 2024 at 08:27
Introduction

Cancer-related lymphoedema is one of the most debilitating side-effects of cancer treatment with an overall incidence of 15.5%. Patients may suffer from a variety of symptoms, possibly resulting in a diminished health-related quality of life (HRQoL). A microsurgical technique known as lymphaticovenous anastomosis (LVA) might be a promising treatment option. The objective of this study is to evaluate whether LVA is effective and cost-effective compared with sham surgery in improving the HRQoL.

Methods and analysis

A multicentre, double-blind, randomised sham-controlled trial conducted in three university hospitals in the Netherlands. The study population comprises 110 patients over the age of 18 years with unilateral, peripheral cancer-related lymphoedema, including 70 patients with upper limb lymphoedema and 40 patients with lower limb lymphoedema. A total of 55 patients will undergo the LVA operation, while the remaining 55 will undergo sham surgery. The follow-up will be at least 24 months. Patients are encouraged to complete the follow-up by explaining the importance of the study. Furthermore, patients may benefit from regular monitoring moments for their lymphoedema. The primary outcome is the HRQoL. The secondary outcomes are the limb circumference, excess limb volume, changes in conservative therapy, postoperative complications, patency of the LVA and incremental cost-effectiveness.

Ethics and dissemination

The study was approved by the Medical Ethical Committee of Maastricht University Medical Center on 20 September 2023 (NL84169.068.23). The results will be presented at scientific conferences and published in peer-reviewed medical journals.

Trial registration number

NCT06082349.

☐ ☆ ✇ BMJ Open

Understanding lived experiences and perceptions of resilience in black and South Asian Muslim children living in East London: a qualitative study protocol

Por: Murray · A. · Durrani · F. · Winstanley · A. · Keiller · E. · Taleb · P. A. · Islam · S. · Foka · S. · Turri · M. G. · Lau · J. Y. F. — Abril 11th 2024 at 04:41
Introduction

It is important to promote resilience in preadolescence; however, there is limited research on children’s understandings and experiences of resilience. Quantitative approaches may not capture dynamic and context-specific aspects of resilience. Resilience research has historically focused on white, middle-class Western adults and adolescents, creating an evidence gap regarding diverse experiences of resilience in middle childhood which could inform interventions. East London’s Muslim community represents a diverse, growing population. Despite being disproportionately affected by deprivation and racial and cultural discrimination, this population is under-represented in resilience research. Using participatory and arts-based methods, this study aims to explore lived experiences and perceptions of resilience in black and South Asian Muslim children living in East London.

Methods and analysis

We propose a qualitative study, grounded in embodied inquiry, consisting of a participatory workshop with 6–12 children and their parents/carers to explore lived experiences and perceptions of resilience. Participants will be identified and recruited from community settings in East London. Eligible participants will be English-speaking Muslims who identify as being black or South Asian, have a child aged 8–12 years and live in East London. The workshop (approx. 3.5 hours) will take place at an Islamic community centre and will include body mapping with children and a focus group discussion with parents/carers to explore resilience perspectives and meanings. Participants will also complete a demographic survey. Workshop audio recordings will be transcribed verbatim and body maps and other paper-based activities will be photographed. Data will be analysed using systematic visuo-textual analysis which affords equal importance to visual and textual data.

Ethics and dissemination

The Queen Mary Ethics of Research Committee at Queen Mary University of London has approved this study (approval date: 9 October 2023; ref: QME23.0042). The researchers plan to publish the results in peer-reviewed journals and present findings at academic conferences.

☐ ☆ ✇ BMJ Open

Qualitative study on the core competencies of nursing personnel in emergency medical rescue teams at comprehensive hospitals in Chongqing, China

Por: Deng · J. · Kou · X. · Ma · H. · Niu · A. · Luo · Y. — Abril 11th 2024 at 04:41
Objective

As an integral part of emergency medical rescue teams during public health events, understanding the core competencies that nursing personnel should possess—including theoretical knowledge, practical skills, comprehensive abilities and personal traits—can provide a practical basis for better preparation and targeted training for future emergency rescue works. Thus, this study aims to provide a scientific and applicable reference for perfecting the routine training strategy of nursing personnel assembled by emergency medical rescue teams and improving the overall guarantee ability level of this group.

Design

This is a qualitative study conducted using individual semi-structured interviews. All interviews were recorded and transcribed verbatim for the purpose of thematic analysis and extraction.

Setting

Participants were recruited from February to March 2023, from four comprehensive hospitals in Chongqing China with the highest number of emergency relief works.

Participants

A sample of experts (N=15) with extensive experience in emergency relief works was recruited in Chongqing, China.

Results

60% of the experts held master’s degrees or higher, 73.3% held senior or higher titles, 36.7% had participated in work execution more than five times and 73.3% held leadership positions in their current units and in the execution of emergency relief works. Four main themes and 22 corresponding subthemes were derived for the core competencies required for nursing personnel selected for emergency medical rescue teams in public health events, including theoretical knowledge, practical skills, comprehensive abilities and personal traits.

Conclusions

Our study revealed that through interviews with 15 experts with extensive experience in the public health event, the essential elements of core competencies for nursing personnel assigned to emergency medical rescue teams during the public health event were identified. These can serve as a reference standard for the selection of nursing personnel in public health events, and provide a basis for the cultivation and evaluation of competency for nursing personnel assigned to emergency medical rescue teams in the public health event in China and globally.

☐ ☆ ✇ BMJ Open

Further development and validation of the Multimorbidity Treatment Burden Questionnaire (MTBQ)

Por: Duncan · P. · Scott · L. J. · Dawson · S. · Munas · M. · Pyne · Y. · Chaplin · K. · Gaunt · D. · Guenette · L. · Salisbury · C. — Abril 11th 2024 at 04:41
Objectives

To undertake further psychometric testing of the Multimorbidity Treatment Burden Questionnaire (MTBQ) and examine whether reversing the scale reduced floor effects.

Design

Survey.

Setting

UK primary care.

Participants

Adults (≥18 years) with three or more long-term conditions randomly selected from four general practices and invited by post.

Measures

Baseline survey: sociodemographics, MTBQ (original or version with scale reversed), Treatment Burden Questionnaire (TBQ), four questions (from QQ-10) on ease of completing the questionnaires. Follow-up survey (1–4 weeks after baseline): MTBQ, TBQ and QQ-10. Anonymous data collected from electronic GP records: consultations (preceding 12 months) and long-term conditions. The proportion of missing data and distribution of responses were examined for the original and reversed versions of the MTBQ and the TBQ. Intraclass correlation coefficient (ICC) and Spearman’s rank correlation (Rs) assessed test–retest reliability and construct validity, respectively. Ease of completing the MTBQ and TBQ was compared. Interpretability was assessed by grouping global MTBQ scores into 0 and tertiles (>0).

Results

244 adults completed the baseline survey (consent rate 31%, mean age 70 years) and 225 completed the follow-up survey. Reversing the scale did not reduce floor effects or data skewness. The global MTBQ scores had good test–retest reliability (ICC for agreement at baseline and follow-up 0.765, 95% CI 0.702 to 0.816). Global MTBQ score was correlated with global TBQ score (Rs 0.77, ps 0.17, p=0.010), and number of different general practitioners consulted (Rs 0.23, ps –0.063, p=0.330). Most participants agreed that both the MTBQ and TBQ were easy to complete and included aspects they were concerned about.

Conclusion

This study demonstrates test–retest reliability and ease of completion of the MTBQ and builds on a previous study demonstrating good content validity, construct validity and internal consistency reliability of the questionnaire.

☐ ☆ ✇ BMJ Open

Effect of transcranial direct current stimulation combined with transcutaneous auricular vagus nerve stimulation on poststroke cognitive impairment: a study protocol for a randomised controlled trial

Por: Liu · W. · Cheng · X. · Zhang · Y. · Liao · W. — Abril 11th 2024 at 04:41
Introduction

Poststroke cognitive impairment is a common complication in stroke survivors, seriously affecting their quality of life. Therefore, it is crucial to improve cognitive function of patients who had a stroke. Transcranial direct current stimulation (tDCS) and transcutaneous auricular vagus nerve stimulation (taVNS) are non-invasive, safe treatments with great potential to improve cognitive function in poststroke patients. However, further improvements are needed in the effectiveness of a single non-invasive brain stimulation technique for cognitive rehabilitation. This study protocol aims to investigate the effect and neural mechanism of the combination of tDCS and taVNS on cognitive function in patients who had a stroke.

Methods and analysis

In this single-centre, prospective, parallel, randomised controlled trial, a total of 66 patients with poststroke cognitive impairment will be recruited and randomly assigned (1:1:1) to the tDCS group, the taVNS group and the combination of tDCS and taVNS group. Each group will receive 30 min of treatment daily, five times weekly for 3 weeks. Primary clinical outcome is the Montreal Cognitive Assessment. Secondary clinical outcomes include the Mini-Mental State Examination, Stroop Colour Word Test, Trail Marking Test, Symbol Digit Modalities Test and Modified Barthel Index. All clinical outcomes, functional MRI and diffusion tensor imaging will be measured at preintervention and postintervention.

Ethics and dissemination

The trial has been approved by the Ethics Committee of the First Affiliated Hospital of Yangtze University (approval no: KY202390). The results will be submitted for publication in peer-reviewed journals or at scientific conferences.

Trial registration number

ChiCTR2300076632.

☐ ☆ ✇ BMJ Open

Association between the triglyceride to high-density lipoprotein cholesterol ratio and mortality in Chinese maintenance haemodialysis patients: a retrospective cohort study

Por: Qi · L. · Zhang · A. · Zhang · Y. · Ren · Z. · Zhao · C. · Wang · Q. · Ren · K. · Bai · J. · Cao · N. — Abril 11th 2024 at 04:41
Objective

To investigate the relationship between the triglyceride to high-density lipoprotein cholesterol (TG/HDL-C) ratio and all-cause and cardiovascular (CV) mortality in Chinese haemodialysis (HD) patients.

Design

Retrospective cohort study.

Setting

Patients from June 2015 to September 2016 and followed through September 2021 were categorised into quartiles according to the follow-up averaged TG/HDL-C ratio. The association between TG/HDL-C and mortality was examined by univariate and multivariate time-varying Cox regression analyses. The C-index was used to assess the predictive accuracy of the Cox regression models.

Participants

A total of 534 maintenance HD patients were enrolled.

Primary and secondary outcome measures

The outcomes were all-cause death and CV mortality.

Results

During the median follow-up of 61 months, 207 patients died, with 94 (45.4%) classified as CV death. After adjusting for confounders, multivariate time-varying Cox regression analysis showed that the quartile 4 group (TG/HDL-C ≥2.64) was associated with decreased all-cause mortality (adjusted HR 0.51, 95% CI 0.33–0.77, p=0.001) and CV mortality (adjusted HR 0.31; 95% CI 0.16 to 0.62; p=0.001) in maintenance HD patients. Model 1 of all-cause mortality achieved a C-index of 0.72 (95% CI 0.68 to 0.75), and model 2 achieved a C-index of 0.77 (95% CI 0.73 to 0.82). The C-index for model 1 in CV mortality was 0.74 (95% CI 0.70 to 0.77), and the C-index for model 2 was 0.80 (95% CI 0.75 to 0.84).

Conclusions

High TG/HDL-C was associated with decreased all-cause and CV mortality in HD patients.

☐ ☆ ✇ BMJ Open

Reporting form and content of research priorities identified in knee osteoarthritis clinical practice guidelines: a methodological literature analysis

Por: Gao · Y. · Liu · Z. · Cao · R. · Feng · Y. · Tao · L. · Su · C. · Guan · X. · Fang · R. · Deng · Y. · Xiang · W. · Fei · Y. — Abril 11th 2024 at 04:41
Objectives

Clinical practice guideline (CPG) developers conduct systematic summaries of research evidence, providing them great capacity and ability to identify research priorities. We systematically analysed the reporting form and content of research priorities in CPGs related to knee osteoarthritis (KOA) to provide a valuable reference for guideline developers and clinicians.

Design

A methodological literature analysis was done and the characteristics of the reporting form and the content of the research priorities identified in KOA CPGs were summarised.

Data sources

Six databases (PubMed, Embase, China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, Wanfang and Chinese Biomedical Literature Database) were searched for CPGs published from 1 January 2017 to 4 December 2022. The official websites of 40 authoritative orthopaedic societies, rheumatology societies and guideline development organisations were additionally searched.

Eligibility criteria

We included all KOA CPGs published in English or Chinese from 1 January 2017 that included at least one recommendation for KOA. We excluded duplicate publications, older versions of CPGs as well as guidance documents for guideline development.

Data extraction and synthesis

Reviewers worked in pairs and independently screened and extracted the data. Descriptive statistics were used, and absolute frequencies and proportions of related items were calculated.

Results

187 research priorities reported in 41 KOA CPGs were identified. 24 CPGs reported research priorities, of which 17 (41.5%) presented overall research priorities for the entire guideline rather than for specific recommendations. 110 (58.8%) research priorities were put forward due to lack of evidence. Meanwhile, more than 70% of the research priorities reflected the P (population) and I (intervention) structural elements, with 135 (72.2%) and 146 (78.1%), respectively. More than half of the research priorities (118, 63.8%) revolved around evaluating the efficacy of interventions. Research priorities primarily focused on physical activity (32, 17.3%), physical therapy (30, 16.2%), surgical therapy (27, 14.6%) and pharmacological treatment (26, 14.1%).

Conclusions

Research priorities reported in KOA CPGs mainly focused on evaluating non-pharmacological interventions. There exists considerable room for improvement for a comprehensive and standardised generation and reporting of research priorities in KOA CPGs.

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