FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerBMJ Open

Cohort profile: the National Congenital Anomaly Registration Dataset in England

Por: Broughan · J. M. · Wreyford · B. · Martin · D. · Melis · G. · Randall · K. · Obaro · E. · Broggio · J. · Aldridge · N. · Stoianova · S. · Johnson · C. · Gibbard · D. · Stevens · S. · Fleming · K. M.
Purpose

The National Congenital Anomaly and Rare Disease Registration Service (NCARDRS), part of National Disease Registration Service in National Health Service England, quality assures, curates and analyses individual data on the pregnancies, fetuses, babies, children and adults with congenital anomalies and rare diseases across England. The congenital anomaly (CA) register provides a resource for patients and their families, clinicians, researchers and public health professionals in furthering the understanding of CAs.

Participants

NCARDRS registers CAs occurring in babies born alive and stillborn, fetal losses and terminations in England. NCARDRS collects data from secondary and tertiary healthcare providers, private providers and laboratories covering fetal medicine, maternity or paediatric services. Data describe the pregnancy, mother, baby and anomaly. Established in 2015, NCARDRS expanded CA registration coverage from 22% of total births in England in 2015 to national coverage, which was achieved in 2018. Prior to 2015, data collection was performed independently by regional registers in England; these data are also held by NCARDRS.

Findings to date

NCARDRS registers approximately 21 000 babies with CAs per year with surveillance covering around 600 000 total births, the largest birth coverage for a CA register globally. Data on prevalence, risk factors and survival for children with CAs are available. Data have been used in several peer-reviewed publications. Birth prevalence statistics, including public health indicators such as the association with maternal age, infant and perinatal mortality, are published annually. NCARDRS supports clinical audit for screening programmes and service evaluation.

Future plans

NCARDRS provides a valuable resource for the understanding of the epidemiology, surveillance, prevention and treatment of CAs. Currently, approximately 21 000 new registrations of babies or fetuses with suspected or confirmed CAs are added each year. Identifiers are collected, enabling linkage to routinely collected healthcare and population statistics, further enhancing the value of the data.

Randomised, siteless study to compare systematic atrial fibrillation screening using enrichment by a risk prediction model with standard care in a Swedish population aged >= 65 years: CONSIDERING-AF study design

Por: Etminani · F. · Sandgren · E. · Holm · J. · Magnusson · P. · Modica · A. · Moberg · K. · Davidsson · T. · Stalpe · L. · Kiflemariam · S. · Younan · N. · Parikh · P. · Wadhwa · M. · Sundin · A. · Engdahl · J.
Introduction

Atrial fibrillation (AF) is the most common arrhythmia and confers an increased risk of mortality, stroke, heart failure and cognitive decline. There is growing interest in AF screening; however, the most suitable population and device for AF detection remains to be elucidated. Here, we present the design of the CONSIDERING-AF (deteCtiON and Stroke preventIon by moDEl scRreenING for Atrial Fibrillation) study.

Methods and analysis

CONSIDERING-AF is a randomised, controlled, siteless, non-blinded diagnostic superiority trial with four parallel groups and a primary endpoint of identifying AF during a 6-month study period set in Region Halland, Sweden. In each group, 740 individuals aged≥65 years will be included. The primary objective is to compare the intervention of AF screening enrichment using a risk prediction model (RPM), followed by 14 days of a continuous ECG patch, with no intervention (standard care). Primary outcome is defined as the incident AF recorded in the Region Halland Information Database after 6 months as compared with standard care. Secondary endpoints include the difference in incident AF between groups enriched or not by the RPM, with and without an invitation to 14 days of continuous ECG recording, and the proportions of oral anticoagulation treatment in the four groups.

Ethics and dissemination

This study has ethical approval from the Swedish Ethical Review Authority. Results will be published in peer-reviewed international journals.

Trial registration number

NCT05838781.

Causes of maternal deaths in Sierra Leone from 2016 to 2019: analysis of districts maternal death surveillance and response data

Por: Shafiq · Y. · Caviglia · M. · Juheh Bah · Z. · Tognon · F. · Orsi · M. · K. Kamara · A. · Claudia · C. · Moses · F. · Manenti · F. · Barone-Adesi · F. · Sessay · T.
Introduction

Sierra Leone is among the top countries with the highest maternal mortality rates. Although progress has been made in reducing maternal mortality, challenges remain, including limited access to skilled care and regional disparities in accessing quality care. This paper presents the first comprehensive analysis of the burden of different causes of maternal deaths reported in the Maternal Death Surveillance and Response (MDSR) system at the district level from 2016 to 2019.

Methods

The MDSR data are accessed from the Ministry of Health and Sanitation, and the secondary data analysis was done to determine the causes of maternal death in Sierra Leone. The proportions of each leading cause of maternal deaths were estimated by districts. A subgroup analysis of the selected causes of death was also performed.

Results

Overall, obstetric haemorrhage was the leading cause of maternal death (39.4%), followed by hypertensive disorders (15.8%) and pregnancy-related infections (10.1%). Within obstetric haemorrhage, postpartum haemorrhage was the leading cause in each district. The burden of death due to obstetric haemorrhage slightly increased over the study period, while hypertensive disorders showed a slightly decreasing trend. Disparities were found among districts for all causes of maternal death, but no clear geographical pattern emerged. Non-obstetric complications were reported in 11.5% of cases.

Conclusion

The MDSR database provides an opportunity for shared learning and can be used to improve the quality of maternal health services. To improve the accuracy and availability of data, under-reporting must be addressed, and frontline community staff must be trained to accurately capture and report death events.

Use of removable support boot versus cast for early mobilisation after ankle fracture surgery: cost-effectiveness analysis and qualitative findings of the Ankle Recovery Trial (ART)

Por: Baji · P. · Barbosa · E. C. · Heaslip · V. · Sangar · B. · Tbaily · L. · Martin · R. · Docherty · S. · Allen · H. · Hayward · C. · Marques · E. M. R.
Objectives

To estimate the cost-effectiveness of using a removable boot versus a cast following ankle fracture from the National Health Service and Personal Social Services (NHS+PSS) payer and societal perspectives and explore the impact of both treatments on participants’ activities of daily living.

Design

Cost-effectiveness analyses and qualitative interviews performed alongside a pragmatic multicentre randomised controlled trial.

Setting

Eight UK NHS secondary care trusts.

Participants

243 participants (60.5% female, on average 48.2 years of age (SD 16.4)) with ankle fracture. Qualitative interviews with 16 participants. Interventions removable air boot versus plaster cast 2 weeks after surgery weight bearing as able with group-specific exercises.

Primary and secondary outcome measures

Quality-adjusted life years (QALYs) estimated from the EQ-5D-5L questionnaire, costs and incremental net monetary benefit statistics measured 12 weeks after surgery, for a society willing-to-pay £20 000 per QALY.

Results

Care in the boot group cost, on average, £88 (95% CI £22 to £155) per patient more than in the plaster group from the NHS+PSS perspective. When including all societal costs, the boot saved, on average, £676 per patient (95% CI –£337 to £1689). Although there was no evidence of a QALY difference between the groups (–0.0020 (95% CI –0.0067 to 0.0026)), the qualitative findings suggest participants felt the boot enhanced their quality of life. Patients in the boot felt more independent and empowered to take on family responsibilities and social activities.

Conclusions

While the removable boot is slightly more expensive than plaster cast for the NHS+PSS payer at 12 weeks after surgery, it reduces productivity losses and the need for informal care while empowering patients. Given that differences in QALYs and costs to the NHS are small, the decision to use a boot or plaster following ankle surgery could be left to patients’ and clinicians’ preferences.

Trial registration number

ISRCTN15497399, South Central—Hampshire A Research Ethics Committee (reference 14/SC/1409).

Feasibility and acceptability of offering breast cancer risk assessment to general population women aged 30-39 years: a mixed-methods study protocol

Por: Hindmarch · S. · Howell · S. J. · Usher-Smith · J. A. · Gorman · L. · Evans · D. G. · French · D. P.
Introduction

Breast cancer incidence starts to increase exponentially when women reach 30–39 years, hence before they are eligible for breast cancer screening. The introduction of breast cancer risk assessment for this age group could lead to those at higher risk receiving benefits of earlier screening and preventive strategies. Currently, risk assessment is limited to women with a family history of breast cancer only. The Breast CANcer Risk Assessment in Younger women (BCAN-RAY) study is evaluating a comprehensive breast cancer risk assessment strategy for women aged 30–39 years incorporating a questionnaire of breast cancer risk factors, low-dose mammography to assess breast density and polygenic risk. This study will assess the feasibility and acceptability of the BCAN-RAY risk assessment strategy.

Methods and analysis

This study involves women undergoing risk assessment as part of the BCAN-RAY case-control study (n=750). They will be aged 30–39 years without a strong family history of breast cancer and invited to participate via general practice. A comparison of uptake rates by socioeconomic status and ethnicity between women who participated in the BCAN-RAY study and women who declined participation will be conducted. All participants will be asked to complete self-report questionnaires to assess key potential harms including increased state anxiety (State Trait Anxiety Inventory), cancer worry (Lerman Cancer Worry Scale) and satisfaction with the decision to participate (Decision Regret Scale), alongside potential benefits such as feeling more informed about breast cancer risk. A subsample of approximately 24 women (12 at average risk and 12 at increased risk) will additionally participate in semistructured interviews to understand the acceptability of the risk assessment strategy and identify any changes needed to it to increase uptake.

Ethics and dissemination

Ethical approval was granted by North West—Greater Manchester West Research Ethics Committee (reference: 22/NW/0268). Study results will be disseminated through peer-reviewed journals, conference presentations and charitable organisations.

Trial registration number

NCT05305963.

Electroacupuncture use for treatment of taxane-induced peripheral neuropathy in patients with breast cancer: protocol for a pilot, randomised, blinded, sham-controlled trial (EA for CIPN)

Por: Choi · V. · Park · S. B. · Lacey · J. · Kumar · S. · Heller · G. · Grimison · P.
Introduction

Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting side effect of neurotoxic chemotherapy. Acute symptoms of CIPN during treatment can lead to dose reduction and cessation. Trials using electroacupuncture (EA) to treat established CIPN postchemotherapy have shown some efficacy. The current trial aims to assess the feasibility and preliminary efficacy of using EA to treat CIPN during chemotherapy.

Methods and analysis

The current study is a single-centre, 1:1 randomised, sham-controlled pilot study set in a tertiary cancer hospital in Sydney, Australia, and will recruit 40 adult patients with early breast cancer undergoing adjuvant or neoadjuvant paclitaxel chemotherapy. Patients who develop CIPN within the first 6 weeks of chemotherapy will receive either true EA or sham-EA once a week for 10 weeks. The coprimary endpoints are recruitment and adherence rate, successful blinding of patients and compliance with the follow-up period. Secondary endpoints are mean change of CIPN symptoms from randomisation to end of treatment, sustained change in CIPN symptoms at 8-week and 24-week follow-up postchemotherapy, proportion of subjects attaining completion of 12 weeks of chemotherapy without dose reduction or cessation, change in acupuncture expectancy response pretreatment, during treatment and posttreatment. The primary assessment tool for the secondary endpoints will be a validated patient-reported outcome measure (European Organisation for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy) captured weekly from randomisation to week 12 of chemotherapy.

Ethics and dissemination

The study protocol (2021/ETH12123) has been approved by the institutional Human Research Ethics Committee at St Vincent’s Hospital Sydney and Chris O’Brien Lifehouse. Informed consent will be obtained prior to starting study-related procedures. The results will be disseminated in peer-reviewed journals and at scientific conferences.

Trial registration number

ACTRN12622000081718.

MISSION ABC: transforming respiratory care through one-stop multidisciplinary clinics - an observational study

Por: Heiden · E. · Longstaff · J. · Chauhan · M. J. A. · DeVos · R. · Lanning · E. · Neville · D. · Jones · T. L. · Begum · S. · Amos · M. · Mottershaw · M. · Micklam · J. · Holdsworth · B. · Rupani · H. · Brown · T. · Chauhan · A. J. · Mission ABC Collaborators · Baghammar · Bannell · Domin
Objectives

The Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness and Chronic Obstructive Pulmonary Disease (COPD) (MABC) service aimed to enhance disease management for chronic respiratory conditions through specialist multidisciplinary clinics, predominantly in the community. This study assesses the outcomes of these clinics.

Design

This study used a prospective, longitudinal, participatory action research approach.

Setting

The study was conducted in primary care practices across Hampshire, UK.

Participants

Adults aged 16 years and above with poorly controlled asthma or COPD, as well as those with undifferentiated breathlessness not under specialist care, were included.

Interventions

Participants received care through the multidisciplinary, specialist-led MABC clinics.

Primary and secondary outcome measures

Primary outcomes included disease activity, quality of life and healthcare utilisation. Secondary outcomes encompassed clinic attendance, diagnostic changes, patient activation, participant and healthcare professional experiences and cost-effectiveness.

Results

A total of 441 participants from 11 general practitioner practices were recruited. Ninety-six per cent of participants would recommend MABC clinics. MABC assessments led to diagnosis changes for 64 (17%) participants with asthma and COPD and treatment adjustments for 252 participants (57%). Exacerbations decreased significantly from 236 to 30 after attending the clinics (p

Conclusions

Specialist-supported multidisciplinary teams in MABC clinics improved diagnosis accuracy and adherence to guidelines. High patient satisfaction, disease control improvements and reduced exacerbations resulted in decreased unscheduled healthcare use and cost savings.

Trial registration number

NCT03096509.

Magnitude and associated factors of cutaneous leishmaniasis among patients visiting Nefas Mewcha primary hospital, Northern Ethiopia, 2022: An institution-based Cross-sectional study

Por: Bantie · B. · Kassaw · G. · Demelash · A. T. · Abate · M. W. · Nigat · A. B. · Amare · A. T. · Birlie · T. A. · Tasew · S. F. · Zeleke · S. · Kassie · A. · Tantigegn · S. · Ambaw · L. A. · Muhamed · A. N. · Melese · B. D.
Background

Cutaneous leishmaniasis (CL) is the most common neglected tropical disease, causing stigmatised skin lesions. It is an important public health concern, with 95% of cases occurring in low-income and middle-income countries. Despite its long-recognized endemicity and psychosocial impacts, it is largely overlooked.

Objective

The main aim of this study is to investigate the magnitude and associated factors of CL in north-central Ethiopia.

Design

An institution-based cross-sectional study was conducted.

Setting

The study was conducted in Nefas Mewcha Primary Hospital (NMPH), north-central Ethiopia.

Participants

The study was conducted among 332 individuals visiting NMPH from June to July 2022.

Primary and secondary outcomes

The primary outcome was to estimate the burden of CL among patients visiting NMPH, and the secondary outcome was to identify factors associated with the presence or absence of CL. The association between predictor variables and CL was assessed using a binary logistic regression model. Statistical significance was declared at a p _value of

Result

Out of the 332 study participants, 63 patients sought medical care with skin lesions, and 61 (18.37%, 95% CI: 14.5% to 22.9%) were patients with CL. Localized CL was the predominant type (86.9%). Male sex (adjusted OR (AOR): 4.51; 95% CI 1.94 to 10.45), older age (AOR 0.91, 95% CI: 0.87 to 0.94), secondary and tertiary educational status (AOR: 0.18, 95% CI: 0.05 to 0.6), poor knowledge of CL (AOR: 4.02, 95% CI: 1.81 to 9.76) and living with domestic animals (AOR: 5.29, 95% CI 3.24 to 7.5) were identified as predictors of CL.

Conclusion

In the study area, the magnitude of CL was found to be high. Being male and young, having low educational status, having poor knowledge and living with domestic animals increase the risk of acquiring CL. As a result, increasing the knowledge of the community through scaling up of health education programmes and reducing activities that increase individuals’ exposure to sandflies should be prioritised.

Comparison of healthcare quality for uninsured and underinsured children through community health centres in Canada and the USA: a scoping review protocol

Por: Suleman · S. · Calleja · S. · Parmar · P. K. · Cohen · E.
Introduction

Children and youth who are uninsured or underinsured in Canada and the USA have limited options where they can receive healthcare. In both countries, community health centres (CHCs) have been established as a solution to provide quality care to children without adequate insurance, including those who are newcomers or refugees. However, little is known about how well these models deliver paediatric care. Cross-country analysis provides an important viewpoint to identify areas of success and growth. The purpose of this scoping review is to compare quality of care for uninsured and underinsured children through CHCs in the USA and Canada.

Methods

This scoping review follows the methodological guidelines from the Joanna Briggs Institute Evidence synthesis. The protocol has been registered with the Open Science Framework Registries and can be accessed online. A search will be conducted in electronic databases of peer-reviewed literature (Ovid MEDLINE ALL, CINAHL Complete via EbscoHost, Scopus; Health Business Elite via EbscoHost and Sociological Abstracts via ProQuest) as well as the grey literature. Two reviewers will review all titles and abstracts for inclusion in full-text review. Studies that meet inclusion criteria will be included in full-text review. Data will be extracted into Covidence, using the Donabedian model as a conceptual framework. Findings will be synthesised in a narrative format.

Ethics and dissemination

As this study only uses publicly available data, ethics approval is not required. Findings will be shared at national and international conferences and published in a peer-reviewed journal. In addition, findings will be prepared into a policy brief or white paper to be shared with relevant policy stakeholders to advocate for a better model of care for marginalised children and youth.

Amantadine and/or transcranial magnetic stimulation for fatigue associated with multiple sclerosis (FETEM): study protocol for a phase 3 randomised, double-blind, cross-over, controlled clinical trial

Por: Matias-Guiu · J. A. · Gonzalez-Rosa · J. · Hernandez · M. A. · Martinez-Gines · M. L. · Portoles · A. · Perez-Macias · N. · Benito-Leon · J. · Padron · I. · Prieto · J. · Matias-Guiu · J.
Introduction

Fatigue is one of the most disabling symptoms of multiple sclerosis (MS), and effective treatments are lacking. Amantadine is one of the most used treatments, although its efficacy is under debate. Transcranial magnetic stimulation (TMS) is a promising intervention that has shown positive effects in some preliminary investigations. We aim to investigate the effect of 6 weeks of amantadine and/or TMS in fatigue due to MS.

Methods and analysis

The study is a national, multicentre, phase 3, randomised, double-blind, cross-over, placebo-controlled and sham-controlled clinical trial. Adult patients with relapsing-remitting MS, Expanded Disability Status Scale score of 1.5–4.5 and Fatigue Severity Score>4 are eligible for the trial. Participants will be randomised to one of the sequences of the study. Each sequence consists of four periods of 6 weeks of treatment and three washout periods of 12–18 weeks. All patients will receive all the combinations of therapies. The primary outcome is the Modified Fatigue Impact Scale. The secondary outcomes are the Symbol Digit Modalities Test (cognition), Beck Depression Inventory-II (depressive symptoms) and Short-Survey 12 (quality of life). Safety and cost-effectiveness will also be evaluated. An exploratory substudy including MRI and blood biomarkers will be conducted.

Ethics and dissemination

The study is approved by the Ethics Committee of the Hospital Clinico San Carlos and the Spanish Agency of Medications and Medical Devices. All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.

Trial registration number

EudraCT 2021-004868-95; NCT05809414.

Adverse outcomes of cannabis use in Canada, before and after legalisation of non-medical cannabis: cross-sectional analysis of the International Cannabis Policy Study

Por: Marquette · A. · Iraniparast · M. · Hammond · D.
Objectives

To date, there is little evidence on the extent to which cannabis legalisation affects the prevalence of adverse events from cannabis at the population level. The current study examined trends in the prevalence of adverse events among people who consumed cannabis before and after Canada’s legalisation of recreational cannabis.

Design

Data come from the first four survey waves of the International Cannabis Policy Study, which were conducted online annually immediately prior to non-medical cannabis legalisation in Canada in October 2018, and in the three following years (2019–2021).

Participants

The current analysis included 18 285 Canadian respondents aged 16–65 who reported cannabis use in the past 12 months.

Outcome measures

Primary outcomes included types of adverse events experienced from cannabis use, medical help-seeking and the types of products used. Weighted logistic regression models examined differences in help-seeking, emergency room usage and the experience of cannabinoid hyperemesis syndrome across survey years.

Results

Approximately one-third of people who consume cannabis reported experiencing at least one adverse event within the past 12 months, including 5% of consumers who sought medical help for an adverse event, most commonly for panic attacks, feeling faint/dizzy/passing out, heart/blood pressure problems and nausea/vomiting. The prevalence of seeking help and the types of adverse events were similar before (2018) and after legalisation (2019–2021); however, the proportion of consumers seeking help from emergency rooms increased postlegalisation (F=2.77, p=0.041). Adverse events were associated with various product types, with dried flower and oral oils accounting for the largest proportion of events. Help-seeking associated with cannabis edibles significantly decreased after legalisation (p=0.001).

Conclusions

Substantial proportions of people who consume cannabis report adverse events, suggesting widespread difficulty in ‘dosing’. Few changes were observed in the prevalence of adverse events reported by consumers since legalisation; however, the location of medical help-seeking and associated products used have changed postlegalisation.

Social and clinical vulnerability in stroke and STEMI management during the COVID-19 pandemic: a registry-based study

Por: Lesaine · E. · Francis · F. · Domecq · S. · Miganeh-Hadi · S. · Sevin · F. · Sibon · I. · Rouanet · F. · Pradeau · C. · Coste · P. · Cetran · L. · Vandentorren · S. · Saillour · F. · AVICOVID group · Faucheux · Leca Radu · Seignolles · Chazalon · Dan · Lucas · Peron · Wong-So · Martinez
Objective

This study aims to evaluate whether the first wave of the COVID-19 pandemic resulted in a deterioration in the quality of care for socially and/or clinically vulnerable stroke and ST-segment elevation myocardial infarction (STEMI) patients.

Design

Two cohorts of STEMI and stroke patients in the Aquitaine neurocardiovascular registry.

Setting

Six emergency medical services, 30 emergency units, 14 hospitalisation units and 11 catheterisation laboratories in the Aquitaine region in France.

Participants

This study involved 9218 patients (6436 stroke and 2782 STEMI patients) in the neurocardiovascular registry from January 2019 to August 2020.

Primary outcome measures

Care management times in both cohorts: first medical contact-to-procedure time for the STEMI cohort and emergency unit admission-to-imaging time for the stroke cohort. Associations between social (deprivation index) and clinical (age >65 years, neurocardiovascular history) vulnerabilities and care management times were analysed using multivariate linear mixed models, with an interaction on the time period (pre-wave, per-wave and post-first COVID-19 wave).

Results

The first medical contact procedure time was longer for elderly (p

Conclusions

This study revealed pre-existing inequalities in care management times for vulnerable STEMI and stroke patients; however, these inequalities were neither accentuated nor reduced during the first COVID-19 wave. Measures implemented during the crisis did not alter the structured emergency pathway for these patients.

Trial registration number

NCT04979208

Stakeholders perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study

Por: Deja · E. · Donohue · C. · Semple · M. G. · Woolfall · K. · for the BESS Investigators · Semple · McNamara · Allen · Fowler · Barker · Peak · Miert · Best · Donohue · Jones · Moitt · Price · Williamson · Clark · Madsen · Dawson · Summers · Deja · Woolfall · Osaghae · Turner · Panchal
Objectives

The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS, including approach to consent within a limited time frame, we explored parent and staff experiences of trial involvement in the first two bronchiolitis seasons to inform subsequent trial conduct.

Design

A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS.

Setting

Fourteen UK paediatric intensive care units.

Participants

Of the 179 parents of children approached to take part in BESS, 75 parents (of 69 children) took part in the embedded study. Of these, 55/69 (78%) completed a questionnaire, and 15/69 (21%) were interviewed. Thirty-eight staff completed a questionnaire.

Results

Parents and staff found the trial acceptable. All constructs of the Adapted Theoretical Framework of Acceptability were met. Parents viewed surfactant as being low risk and hoped their child’s participation would help others in the future. Although parents supported research without prior consent in studies of time critical interventions, they believed there was sufficient time to consider this trial. Parents recommended that prospective informed consent should continue to be sought for BESS. Many felt that the time between the consent process and intervention being administered took too long and should be ‘streamlined’ to avoid delays in administration of trial interventions. Staff described how the training and trial processes worked well, yet patients were missed due to lack of staff to deliver the intervention, particularly at weekends.

Conclusion

Parents and staff supported BESS trial and highlighted aspects of the protocol, which should be refined, including a streamlined informed consent process. Findings will be useful to inform proportionate approaches to consent in future paediatric trials where there is a short timeframe for consent discussions.

Trial registration number

ISRCTN11746266.

Optimisation of Organ Preservation treatment strategies in patients with rectal cancer with a good clinical response after neoadjuvant (chemo)radiotherapy: Additional contact X-ray brachytherapy versus eXtending the observation period and local excision (

Por: Geubels · B. M. · van Triest · B. · Peters · F. P. · Maas · M. · Beets · G. L. · Marijnen · C. A. M. · Custers · P. A. · Rutten · H. J. T. · Theuws · J. C. M. · Verrijssen · A.-S. E. · Cnossen · J. S. · Burger · J. W. A. · Grotenhuis · B. A.
Introduction

Standard treatment for patients with intermediate or locally advanced rectal cancer is (chemo)radiotherapy followed by total mesorectal excision (TME) surgery. In recent years, organ preservation aiming at improving quality of life has been explored. Patients with a complete clinical response to (chemo)radiotherapy can be managed safely with a watch-and-wait approach. However, the optimal organ-preserving treatment strategy for patients with a good, but not complete clinical response remains unclear. The aim of the OPAXX study is to determine the rate of organ preservation that can be achieved in patients with rectal cancer with a good clinical response after neoadjuvant (chemo)radiotherapy by additional local treatment options.

Methods and analysis

The OPAXX study is a Dutch multicentre study that investigates the efficacy of two additional local treatments aiming at organ preservation in patients with a good, but not complete response to neoadjuvant treatment (ie near-complete response or a small residual tumour mass

Ethics and dissemination

The trial protocol has been approved by the medical ethics committee of the Netherlands Cancer Institute (METC20.1276/M20PAX). Informed consent will be obtained from all participants. The trial results will be published in an international peer-reviewed journal.

Trial registration number

NCT05772923.

Antibiotic use among hospitalised patients in Sierra Leone: a national point prevalence survey using the WHO survey methodology

Por: Kamara · I. F. · Kanu · J. · Maruta · A. · Fofanah · B. D. · Kamara · K. N. · Sheriff · B. · Katawera · V. · D'Almeida · S. A. · Musoke · R. · Nuwagira · I. · Lakoh · S. · Kamara · R. Z. · Tengbe · S. M. · Mansaray · A. R. · Koroma · Z. · Thomas · F. · Abiri · O. T. · Koroma · A. T. · Russ
Objective

Inappropriate use of antibiotics is a major driver of antibiotic resistance. A few studies conducted in Africa have documented that about half of hospitalised patients who receive antibiotics should not have received them. A few hospital-based studies that have been conducted in Sierra Leone have documented a high usage of antibiotics in hospitals. Therefore, we conducted a nationwide point prevalence survey on antibiotic use among hospitalised patients in Sierra Leone.

Design

We conducted a hospital-based, cross-sectional survey on the use of antibiotics using the WHO point prevalence survey methodology.

Setting

The study was conducted in 26 public and private hospitals that are providing inpatient healthcare services.

Participants

All patients admitted to paediatric and adult inpatient wards before or at 08:00 on the survey date were enrolled.

Outcome measures

Prevalence of antibiotic use, antibiotics Access, Watch and Reserve (AWaRe) categorisation, indication for antibiotic use prevalence and proportion of bacteria culture done.

Results

Of the 1198 patient records reviewed, 883 (73.7%, 95% CI 71.1% to 76.2%) were on antibiotics. Antibiotic use was highest in the paediatric wards (306, 85.7%), followed by medical wards (158, 71.2%), surgical wards (146, 69.5%), mixed wards (97, 68.8%) and lowest in the obstetrics and gynaecology wards (176, 65.7%). The most widely prescribed antibiotics were metronidazole (404, 22.2%), ceftriaxone (373, 20.5%), ampicillin (337, 18.5%), gentamicin (221, 12.1%) and amoxicillin (90, 5.0%). Blood culture was only done for one patient and antibiotic treatments were given empirically. The most common indication for antibiotic use was community-acquired infection (484, 51.9%) followed by surgical prophylaxis (222, 23.8%).

Conclusion

There was high usage of antibiotics in hospitals in Sierra Leone as the majority of patients admitted received an antibiotic. This has the potential to increase the burden of antibiotic resistance in the country. We, therefore, recommend the establishment of hospital antimicrobial stewardship programmes according to the WHO core components.

Medical students impacted by discrimination: a qualitative study into their experiences of belonging and support systems at medical schools in the UK

Por: Ikhlaq · H. · Agarwal · S. · Kwok · C. · Golamgouse · H. · Derby · S. · McRae · N. · Brown · M. E. L. · Collin · V. · Parekh · R. · Kumar · S.
Objective

To better understand the broader experience of medical students impacted by discrimination and the support systems they engage with.

Design

Qualitative study using semi-structured interviews.

Setting

Four medical schools based in the UK.

Participants

17 medical students were recruited using volunteer and snowball sampling: all students self-identified as being impacted by discrimination.

Results

5 themes were identified: feelings of isolation, imposter syndrome and exclusion; a lack of representation and positive role modelling; the importance of peer support; issues relating to the accessibility of support; building support networks through shared experiences and attempts to foster a sense of inclusion through peer and institutionally led initiatives.

Conclusions

The findings of this study suggest medical schools could do more to recognise the importance of acknowledging the multiple identities at risk of discrimination held by students, perpetuating feelings of isolation and exclusion. Our research highlights the need for practical systemic initiatives to improve the sense of belonging of medical students who are impacted by discrimination. Medical educators and institutions should consider formal and informal provisions, such as creating time and space for students to meet and share experiences, access support and reporting networks, to foster a greater sense of belonging.

Analysis of cardiovascular risk factors for the viability of cornea donors: a case-control study

Objective

The main objective of the study was to evaluate the influence of arterial hypertension, diabetes, dyslipidaemia, smoking, alcoholism and COPD (chronic obstructive pulmonary disease) on the viability of the extracted tissue as well as the donor.

Design

Observational case–control study.

Setting

Regional hospital in Northern Spain.

Participants

1517 corneas were registered.

Interventions

Patients’ medical history was reviewed after corneal donation and evaluation. Previous medical information (age, sex and cardiovascular risk factors (CVRFs)) and data related to the donor (type of donor), the corneal tissue and its evaluation, and the viability of the implant were collected.

Results

A total of 1517 corneas were registered and 81.5% of the donors presented at least one CVRF. In relation to the viability of the donor, it was observed that having suffered from COPD reduced the viability of the donor (no COPD: 93.8% vs COPD: 88%; OR=0.49; 95% CI: 0.28 to 0.84) while alcohol consumption increased it (drinker or ex-drinker: 95.8% vs non-drinker: 92.5%; OR=1.84; 95% CI: 1.01 to 3.33). Regarding tissue viability, decreased viability was observed in the presence of COPD (no COPD: 72.5% vs COPD: 64; OR=0.67; 95% CI: 0.47 to 0.96) and diabetes mellitus (no diabetes: 72.9% vs diabetes: 67.2%; OR=0.76; 95% CI: 0.58 to 0.99). As regards the viability of the implant, a total of 1039 corneas (68.9%) were suitable, observing decreased viability when suffering from COPD (no COPD: 69.8% vs COPD: 60.7%; OR=0.67; 95% CI: 0.47 to 0.94) and increased when having an active smoking habit (no habit: 65.3% vs habit: 74.1%; OR=1.52; 95% CI: 1.21 to 1.91).

Conclusions

Through this study, it can be concluded that in the absence of absolute exclusion criteria for donors, the assessment of how CVRF, alcoholism and COPD may affect the donor provides details about the quality of the tissue to be obtained.

Defining anthropometric thresholds (mid-arm circumference and calf circumference) in older adults residing in the community: a cross-sectional analysis using data from the population representative Longitudinal Aging Study in India (LASI DAD)

Por: Bhagwasia · M. · Rao · A. R. · Banerjee · J. · Bajpai · S. · Khobragade · P. Y. · Raman · A. V. · Talukdar · A. · Jain · A. · Rajguru · C. · Sankhe · L. · Goswami · D. · Shanthi · G. S. · Kumar · G. · Varghese · M. · Dhar · M. · Gupta · M. · Koul · P. A. · Mohanty · R. R. · Chakrabarti · S.
Objectives

To identify factors associated with malnutrition (undernutrition and overnutrition) and determine appropriate cut-off values for mid-arm circumference (MAC) and calf circumference (CC) among community-dwelling Indian older adults.

Design

Data from the first wave of harmonised diagnostic assessment of dementia for Longitudinal Ageing Study in India (LASI-DAD) were used. Various sociodemographic factors, comorbidities, geriatric syndromes, childhood financial and health status were included. Anthropometric measurements included body mass index (BMI), MAC and CC.

Setting

Nationally representative cohort study including 36 Indian states and union territories.

Participants

4096 older adults aged >60 years from LASI DAD.

Outcome measures

The outcome variable was BMI, categorised as low (2), normal (18.5–22.9 kg/m2) and high (>23 kg/m2). The cut-off values of MAC and CC were derived using ROC curve with BMI as the gold standard.

Results

902 (weighted percentage 20.55%) had low BMI, 1742 (44.25%) had high BMI. Undernutrition was associated with age, wealth-quintile and impaired cognition, while overnutrition was associated with higher education, urban living and comorbidities such as hypertension, diabetes and chronic heart disease. For CC, the optimal lower and upper cut-offs for males were 28.1 cm and >31.5 cm, respectively, while for females, the corresponding values were 26 cm and >29 cm. Similarly, the optimal lower and upper cut-offs for MAC in males were 23.9 cm and >26.9 cm, and for females, they were 22.5 cm and >25 cm.

Conclusion

Our study identifies a high BMI prevalence, especially among females, individuals with higher education, urban residents and those with comorbidities. We establish gender-specific MAC and CC cut-off values with significant implications for healthcare, policy and research. Tailored interventions can address undernutrition and overnutrition in older adults, enhancing standardised nutritional assessment and well-being.

From intentions to practices: what drove people to get the COVID-19 vaccine? Findings from the French longitudinal socioepidemiological cohort survey

Por: Spire · A. · Sireyjol · A. · Bajos · N. · for the EpiCoV study group · for the EpiCov study group · Bajos · Warszawski · Baghein · Counil · Jusot · Lydie · Martin · Meyer · Raynaud · Rouquette · Pailhe · Pousson · Rahib · Sillard · Spire
Objective

In many countries, before COVID-19 vaccines became available, reluctance to get vaccinated was particularly prevalent among women, the most disadvantaged social groups and ethnoracial minorities, known to be at higher risk for the virus. Using a longitudinal perspective, we analyse the social determinants that are associated with the transition from attitudes towards vaccination to actual vaccination practices.

Design

Representative population-based prospective cohort.

Settings

From November 2020 to July 2021.

Participants

Adults included in the Epidemiology and Living Conditions (EpiCoV) cohort (n=86 701).

Main outcome measures

Attitudes towards vaccination in November 2020 before COVID-19 vaccines were available in France (in January 2021) and vaccination practices in July 2021.

Results

Among those who were initially reluctant in November 2020, the youngest, the poorest 10% (OR=0.68, 0.59–0.77), non-European immigrants (OR=0.72, 0.59–0.88) and descendants of non-European immigrants (OR=0.72, 0.61–0.86) were less likely to be vaccinated in July 2021, irrespective of trust in government and scientists. The same social factors were associated with non-vaccination among those who initially were undecided or who favoured vaccination.

Conclusion

Despite the fact that COVID-19 vaccines were relatively available and free of charge in France in July 2021, social inequalities in vaccination against the virus remained the same than those observed in vaccination reluctance in November 2020, before vaccines were available. While adjusting for trust, migration background, younger age and lower income were associated with lower vaccination uptake irrespective of initial intention. By neglecting to genuinely target specific groups that were initially reluctant to be vaccinated, vaccination policies contributed to strengthening pre-existing social inequalities around COVID-19 burden.

Behavioural and social drivers of COVID-19 vaccination in Vietnam: a scoping review

Por: Tran · L. · Dang · T. · Nguyen · M. · Kaufman · J. · Overmars · I. · Shrestha · S. · Abdi · I. · Nguyen · T. · Marahajan · M. · Chu · T. · Danchin · M. · Fox · G. · Nguyen · T. A.
Background

Understanding of the behavioural and social drivers (BeSD) of vaccination is key to addressing vaccine hesitancy and accessibility issues. Vietnam’s national COVID-19 vaccination programme resulted in high uptake of primary doses among adults, but lower booster doses for adults and primary doses for 5–11 years. This scoping review assessed BeSD influencing COVID-19 vaccine uptake in Vietnam to design interventions on reaching the national vaccination targets.

Method

We conducted a scoping review by searching PubMed, MedRxiv, LitCOVID, COVID-19 LOVE platform, WHO’s COVID-19 research database and seven dominant Vietnamese language medical journals published in English or Vietnamese between 28 December 2019 and 28 November 2022. Data were narratively synthesised and summarised according to the four components of the WHO BeSD framework. The drivers were then mapped along the timeline of COVID-19 vaccine deployment and the evolution of the pandemic in Vietnam.

Results

We identified 680 records, of which 39 met the inclusion criteria comprising 224 204 participants. Adults’ intention to receive COVID-19 vaccines for themselves (23 studies) ranged from 58.0% to 98.1%. Parental intention to vaccinate their under 11-year-old children (six studies) ranged from 32.8% to 79.6%. Key drivers of vaccination uptake were perceived susceptibility and severity of disease, perceived vaccine benefits and safety, healthcare worker recommendation, and positive societal perception. Commonly reported COVID-19 vaccines’ information sources (six studies) were social and mainstream media (82%–67%), television (72.7%–51.6%) and healthcare workers (47.5%–17.5%). Key drivers of COVID-19 uptake remained consistent for both adults and children despite changes in community transmission and vaccine deployment.

Conclusion

Key enablers of vaccine uptake for adults and children included perceived disease severity, perceived vaccine benefits and safety and healthcare worker recommendations. Future studies should assess vaccine communication targeted to these drivers, national policies and political determinants to optimise vaccine uptake.

❌