BMJ Open最新文献

Introduction: Postsurgical hypoparathyroidism (PoSH) is an iatrogenic condition that occurs as a complication of several different procedures with thyroid surgery being the most common. PoSH has significant short- and long-term morbidities. The volume of thyroid surgery is increasing, and PoSH is therefore likely to increase. Some studies have shown promising results using near-infrared fluorescence (NIRF) imaging in reducing the risk of PoSH which has the potential to significantly reduce morbidity and costs associated with monitoring and treatment.

Methods and analysis: NIFTy is an unblinded, parallel group, multicentre, seamless phase II/III randomised controlled trial in patients undergoing total or completion thyroidectomy. The trial incorporates a process evaluation (IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up framework) 2a) to inform the trial protocol, a phase II (IDEAL 2b) analysis using a surrogate primary outcome of 1 day transient hypocalcaemia to determine early futility and phase III (IDEAL 3) assessment of the primary outcome of PoSH at 6 months after surgery. 454 participants will be randomised on a 1:1 basis to evaluate thyroid surgery with NIRF and indocyanine green against standard thyroid surgery in reducing PoSH at 6 months after surgery, with the phase II analysis occurring once data are available for 200 participants. Analysis in both phases will be using multilevel logistic regression incorporating random effects with respect to surgeon and adjusting for minimisation factors. Phase III secondary outcomes include protracted hypoparathyroidism, hypercalcaemia, complications, length of stay, readmissions and patient reported quality of life using the Short Form 36 Health Survey Questionnaire and Hypoparathyroid Patient Questionnaire instruments.

Ethics and dissemination: NIFTy is funded by National Institute for Health and Care Research Efficacy and Mechanism Evaluation Programme (Grant Ref: 17/11/27) and approved by a Research Ethics Committee (reference: 21/WA/0375) and Health Research Authority (HRA). Trial results will be disseminated through conference presentations, peer-reviewed publication and through relevant patient groups.

Trial registration number: ISRCTN59074092.

Introduction: Gastric cancer is a major global health concern, being the final stage of a long-term process, primarily associated with Helicobacter pylori (H. pylori) infection. Early childhood acquisition of H. pylori with low spontaneous eradication rates underscores the need for preventive measures. Our previous pilot treatment study revealed high eradication rates, favourable tolerance profile and a decline in serum biomarkers indicative of gastric damage in asymptomatic school-aged children. The purpose of this study is to determine the potential benefit of a 'screen-and-treat' strategy targeting persistently infected, asymptomatic adolescents. Specific aims are to assess eradication efficacy, its clinical and molecular outcomes and potential clinical and microbiological side effects.

Methods and analysis: The screening phase will involve testing 500-1000 asymptomatic adolescents aged 14-18 from three cities in Chile using the urea breath test (UBT) to identify 210 participants with persistent infection. They will proceed to a randomised, non-blinded, controlled trial, receiving either a sequential eradication scheme for H. pylori or no treatment. Follow-up will span up to 24 months post-treatment, involving UBT, gastroenterological assessments and blood and stool sample collections. Concurrently, a subset of 60 uninfected adolescents will undergo matched follow-up. Enzyme-linked immunosorbent assay (ELISA) commercial kits will evaluate gastric damage biomarkers in serum (pepsinogen I and II, gastrin-17, VCAM-1, CXCL13). Stool samples will be employed for Escherichia coli and Enterococcus spp-culture, assessing AMR via the disk diffusion method. H. pylori clarithromycin resistance will be determined by molecular method from stool samples. The gut microbiome will be characterised by amplifying and sequencing the 16S rRNA gene from stool samples, followed by bioinformatics analysis.

Ethics and dissemination: Approved by the Human Research Ethics Committee at the Faculty of Medicine, University of Chile (073-2022). Findings will be disseminated in peer-reviewed journals and scientific meetings to guide future practices.

Trial registration number: NCT05926804.

Introduction: Postacute sequelae of SARS-CoV-2 infection (PASC) are extensive. Also known as long COVID, primary outcomes reported are neurologic, cardiac and respiratory in nature. However, several studies have also reported an increase in gastrointestinal (GI) symptoms and syndromes following COVID-19. This study of PASC will include extensive analyses of GI symptoms, determine if people with pre-existing irritable bowel syndrome (IBS) are at higher risk of developing PASC generally or PASC-GI, and which biomarkers are impacted and to what degree. This R01 study is being funded by the National Institute of Diabetes and Digestive and Kidney Diseases (1R01DK135483-01) from 2023 to 2028.

Methods and analyses: This study combines a longitudinal epidemiologic cohort study and in-depth, novel biologic analyses. In collaboration with a pre-existing study, the Arizona CoVID-19 Cohort (CoVHORT)-GI will recruit participants based on the history of COVID infection(s), new or ongoing GI symptoms 3-6 months postinfection, and pre-existing or incident IBS diagnosis to represent five study groups for comparison and analyses. A subset (n=1000) of those recruited will submit both stool and blood samples. Both samples will undergo a novel method to quantitate humoral and mucosal immune responses to host-derived faecal communities in conjunction with magnetic bead-based separation and high-depth shotgun microbial sequencing. Stool samples will also undergo traditional microbiome analyses (diversity and abundance) and faecal calprotectin assays. Additional serum analyses will aim to determine if a proteomics-based signature exists that differentiates a unique biomarker compositional signature discriminating PASC-GI versus no PASC. All laboratory data will be linked with in-depth epidemiologic data on demographics, symptoms and chronic conditions.

Ethics and dissemination: This study involves human participants and was approved by the University of Arizona Institutional Review Board (IRB (#00002332) and has been deemed minimal risk. Participants gave informed consent to participate in the study before taking part. All publications from the study will be shared back to participants along with alternative lay summaries and webinars to communicate key findings. The data management plan has been published and is publicly available online, including protocols for data requests.

Introduction: Atrial fibrillation (AF) affects approximately 2.5% of the UK population, with a risk of 1 in 3-5 individuals after the age of 45 years. The global prevalence has risen sharply in the past two decades, from 33.3 million to 59 million individuals living with AF, and is associated with stroke, heart failure and mortality. Catheter ablation is commonly used for symptomatic patients to restore normal rhythm. A recent Cochrane review of randomised clinical trials (RCTs) has demonstrated that exercise training may induce positive effects on AF burden, AF severity, exercise capacity, and quality of life. The aim was therefore to investigate the feasibility of delivering exercise-based cardiac rehabilitation for patients with AF receiving catheter ablation within usual care in the UK.

Methods and analysis: A two-armed feasibility RCT with embedded process evaluation will be undertaken as a phased programme of work. Patients on a waiting list for catheter ablation will be offered a referral to cardiac rehabilitation. The intervention consists of supervised exercise sessions run by a clinical exercise physiologist and psychoeducation sessions. The trial (n=60) will involve one National Health Service (NHS) research site enrolling patients to assess intervention and study design processes. Primary outcomes are recruitment rate, adherence to exercise-based cardiac rehabilitation and loss to follow-up. Semistructured interviews and focus groups with patients and clinicians will be used to gather data on the acceptability of the intervention and study procedures. Secondary outcome measures will be taken at baseline (pre-intervention), post-intervention and at 6-month follow-up and will consist of AF burden, AF recurrence, quality of life, exercise capacity measured by peak oxygen consumption and echocardiographic parameters.

Ethics and dissemination: The trial was approved in the UK by the Northwest-Preston Research Ethics Committee (24/NW/0061; IRAS project ID: 330155). Results will be published in peer-reviewed journals and presented at national and international scientific meetings, and summaries will be communicated to participants.

Trial registration number: Clinicaltrials.gov identifier: NCT06401148.

Objective: To evaluate the knowledge, attitude and practice (KAP) regarding screening and managing diabetic microvascular complications, encompassing diabetic retinopathy (DR), diabetic kidney disease (DKD) and diabetic neuropathy (DN), among general practitioners (GPs).

Design: Cross-sectional study.

Setting: The online questionnaire survey was conducted between April and July 2023.

Participants: GPs from community health centres (CHCs) in all 16 districts of Shanghai were recruited.

Primary and secondary outcome measures: The data of sociodemographic characteristics, KAP scales, training experience and screening instruments for community screening and managing diabetic microvascular complications were collected. Multiple stepwise linear regression was used to explore the influencing factors of KAP. Restricted cubic spline curves with four knots (5%, 35%, 65%, 95%) were used to determine the association between KAP score and duration of general practice.

Results: A total of 1243 questionnaires were included in the analysis. The total KAP score was 66.6±8.8/100, and the knowledge, attitude and practice scores were 64.7±8.7, 83.5±10.5 and 51.6+17.8, respectively. Male (β=-2.419, p=0.012), shorter practice duration (β=-1.033, p=0.031), practice in rural area (β=3.230, p=0.001), not attending training in diabetic microvascular complications (β=-6.346, p<0.001), not managing diabetic patients (β=-4.503, p<0.001), less number of diabetes patients under management (β=-0.007, p=0.035), less number of screening instruments based on self-report of GP (β=-1.681, p<0.001), lower knowledge score (β=-0.190, p<0.001) and lower attitude score (β=-0.414, p<0.001) were associated with lower practice score of GPs. The KAP total score increased with the working years of general practice; however, this effect was no longer observed in knowledge score after 15 years, while the attitude and practice scores showed a continuously increasing trend.

Conclusions: GPs showed insufficient knowledge and poor clinical practice on screening and managing diabetic microvascular complications. There is an urgent need to improve their capacity to provide better care for those with diabetic microvascular complications through targeted training.

Objectives: Traditionally, patients have had passive roles in medical education; however, there have been increasing efforts to partner with communities to create authentic representation of laypeople in medical education. Communities' perspectives of these initiatives have rarely been reported in the literature. This study explores the perspectives of members of community-based organisations (CBOs) who were partnered with a community engagement programme for intercalating medical students at Imperial College London.

Design: A qualitative study using semistructured interviews was conducted, employing reflexive thematic analysis.

Setting: London, UK.

Participants: A total of five participants (one member from five CBOs who agreed to participate) were interviewed for this study. The selection criterion was direct involvement in the community engagement programme.

Results: Three key themes were identified aligning with the core principles of co-production: building partnership, reciprocity in partnership and maintenance of relationship. Partnership development was influenced by the CBOs' perception of students which caused power differentials in the development of learning plans. Reciprocity refers to a multidirectional benefit pathway resulting from the community involvement programme, which had short-term and anticipated long-term effects. Relationships built were maintained via a service evaluation report, and participants discussed how attitudes of academic institutions towards collaboration influence communities' ability to participate in medical education.

Conclusions: The perspectives of CBOs reported in this study demonstrate that factors important to partnership development in community-engaged medical education are consistent with the key principles of co-production. Supported by literature, the findings emphasise that community involvement can be linked to social accountability and sustainable health practice. Provided that the possible risks/challenges are appropriately identified and mitigated to facilitate co-productive partnerships between stakeholders, the involvement of CBOs in medical education has the potential to provide benefits for communities, students and educational institutions.

Introduction: Infant mortality in low or middle-income countries (LoMICs) is still triple that of high-income countries (HICs), and the high mortality burden regions are also weighed down by a triple or quadruple burden of disease such as HIV and tuberculosis; chronic illness; mental health; injury and violence; and maternal, neonatal and child mortality. Emerging data suggest that the sudden unexpected death in infancy (SUDI) burden in LoMICs is at least 10-fold that in HICs. While ending preventable deaths in the neonatal period has received some global attention, the postnatal period where SUDIs occur is a poorly understood and data-poor area in LoMICs. We propose conducting a systematic review to evaluate the burden and trends of SUDIs in LoMICs since 2004.

Methods and analysis: We will systematically search PubMed, Web of Science, Scopus, African Index Medicus, EBSCOHost, Google Scholar, WHOIS and WHO database to identify studies published from July 2004 until October 2024. Two reviewers will screen titles and abstracts and select full-text articles independently for review. We will use the tool developed by the South African Medical Research Council-Burden of Disease Review Manager (BODRevMan)-to assess the risk of bias for each included study. Risk of bias will be assessed for each included study. Information on the prevalence and/or incidence of SUDI and its subcategories and case definitions will be extracted from each article. Where possible, data on prevalence, incidence and subcategories will be pooled using a random effects meta-analysis to account for variability between estimates. The I² statistic will establish the level of heterogeneity due to variation in estimates rather than chance. Results will be presented in tables and graphs. The systematic review will be reported according to the PRISMA 2020 checklist.

Ethics and dissemination: Ethical approval is not required as this is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations.

Prospero registration number: CRD42023466162.

Introduction: Long-acting insulin analogues are the standard of care for people with type 1 diabetes (T1D) in high-income countries but remain largely inaccessible and understudied in low-resource settings. In settings where glycaemic control is typically poor and food insecurity is common, long-acting insulin analogues may offer tangible clinical benefits for people with T1D. To determine whether insulin glargine, a long-acting insulin analogue, reduces the risk of serious hypoglycaemia and/or improves glycaemic time-in-range (TIR) versus human insulin regimens in this population, we are conducting the Human vs Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings randomised controlled trial.

Methods and analysis: This is a 1:1 randomised, parallel-group clinical trial comparing biosimilar insulin glargine with human insulin (Neutral Protamine Hagedorn (NPH) or premixed 70/30 insulin) in 400 youth with type 1 diabetes (T1D) recruiting in Dhaka, Bangladesh (n=250) and Mwanza, Tanzania (n=150). Blinded continuous glucose monitors will be used to assess glycaemic control in both study arms over 14-day periods at baseline and at 3, 6 and 12 months after randomisation. The co-primary outcomes are the per cent time in serious hypoglycaemia (<54 mg/dL) and TIR (70-180 mg/dL) at 6 months of follow-up. Secondary outcomes include TIR at 12 months and time-in-hypoglycaemia, time-above-range, nocturnal hypoglycaemic events and glycaemic control (ie, haemoglobin A1C (HbA1c)) at 6- and 12-months of follow-up. Treatment satisfaction and quality of life are assessed at baseline, 6- and 12 month follow-up. Additionally, the study is conducting qualitative interviews, quantitative assessments of treatment satisfaction and quality of life, as well as assessing the cost-effectiveness of analogue insulin use in low-resource settings.

Ethics and dissemination: This study was approved by the Institutional Review Board at the University of Pittsburgh (STUDY21110122), the National Health Research Ethics Committee at the National Institute for Medical Research in Tanzania (NIMR/HQ/R.8a/Vol.IX/4265) and the Ethical Review Committee (ERC) of Diabetic Association of Bangladesh (BADAS-ERC/EC/22/405). Research findings will be shared by the local partner organisations and institutions with relevant stakeholders including youth living with diabetes, policy makers, healthcare workers and the general public. Findings will also be shared at local, regional and international scientific meetings.

Trial registration number: ClinicalTrials.gov: NCT05614089.

Introduction: Type 1 diabetes (T1D) is an autoimmune-mediated disorder caused by the destruction of pancreatic beta cells. Although there is an underlying genetic predisposition to developing T1D, the trigger is multifactorial and likely includes environmental factors. The intestinal microbiome has been identified as one such factor. Previous studies have illustrated differences in the microbiota of people with T1D compared with healthy controls. This study aims to describe the evolution of the microbiome and metabolome during the first year of clinical T1D, or stage 3 T1D diagnosis, and investigate whether there are differences in the microbiome and metabolome of children who present with and without diabetic ketoacidosis. The study will also explore possible associations between the microbiome, metabolome, glycaemic control and beta cell reserve.

Methods and analysis: This prospective cohort study will include children with newly diagnosed T1D and sibling controls (n=100, males and females) and their faecal microbiome will be characterised using shotgun metagenomic sequencing at multiple time points during the first year of diagnosis. We will develop a microbial culture biobank based on culturomic studies of stool samples from the healthy controls that will support future investigation. Metabolomic analysis will aim to identify additional biomarkers which may be involved in disease presentation and progression. Through this initial exploratory study, we aim to identify specific microbial biomarkers which may be used as future interventional targets throughout the various stages of T1D progression.

Ethics and dissemination: This study has been approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals. Study results will be available to patients with T1D and their families, carers, support networks and microbiome societies and other researchers.

Trial registration number: The clinicaltrials.gov registration number for this trial is NCT06157736.

Objectives: Cement and most other materials used by bricklayers and brick masons for construction purposes could heighten the risk for occupational skin diseases (OSDs) which mostly include occupational contact dermatitis (OCD) and others. The activities of the bricklayers or brick masons are essentially manual as they work as artisans involving mixing sands and gravels with cement and water for building and block moulding, respectively. This can lead to a significant decline in the quality of life and psychosocial function. We determined the prevalence of OSDs and their correlates among bricklayers and brick masons.

Design: This was a comparative case-control study which involved 200 bricklayers/brick masons and 200 healthy non-bricklayers/non-brick masons.

Settings: This study was carried out in two local governments (LGAs) in Ogbomoso community.

Methods: Respondents were selected using a multistage random sampling technique. Interviewer-administer semi-structured questionnaire was used to collect data. Data were analysed using descriptive statistics, the prevalence of OCD and other OSD were determined, χ² test and logistic regression were obtained. A p<0.05 was considered as statistically significant.

Results: The mean age of the bricklayers/brick masons was 39.74±17.03 years, while that of the control group was 40.04±17.24 years. The prevalence of OCD was significantly higher in the bricklayers/brick masons (43.0%) than controls (5.5%), p<0.001. Other dermatological conditions were more common among the cases (8.5%) than the controls (5.0%), p=0.04. Bricklayers/brick masons not using personal protective equipment (PPE, hand gloves) were three times more likely to develop OCD compared with those who used them (OR=3.38, 95% CI 0.12 to 0.72, p=0.007). A family history of allergy is also a predictor of OCD (OR=2.69, 95% CI 1.30 to 5.60, p=0.008).

Conclusion: OSD are common in bricklayers/brick masons, especially among those without the use of PPE. Regular educational programmes emphasizing the need to reduce direct contact with cement including the proper and regular use of PPE among this population group are advised.