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Association between septic shock and tracheal injury score in intensive care unit patients with invasive ventilation: a prospective single-centre cohort study in China

Por: Zhang · P. · Yang · Q. · Yin · C. · Cai · Z. · Lu · H. · Li · H. · Li · L. · Tian · Y. · Bai · L. · Huang · L.
Objectives

There was no evidence regarding the relationship between septic shock and tracheal injury scores. Investigate whether septic shock was independently associated with tracheal injury scores in intensive care unit (ICU) patients with invasive ventilation.

Design

Prospective observational cohort study.

Setting

Our study was conducted in a Class III hospital in Hebei province, China.

Participants

Patients over 18 years of age admitted to the ICU between 31 May 2020 and 3 May 2022 with a tracheal tube and expected to be on the tube for more than 24 hours.

Primary and secondary outcome measures

Tracheal injuries were evaluated by examining hyperaemia, ischaemia, ulcers and tracheal perforation by fiberoptic bronchoscope. Depending on the number of lesions, the lesions were further classified as moderate, severe or confluent.

Results

Among the 97 selected participants, the average age was 56.6±16.5 years, with approximately 64.9% being men. The results of adjusted linear regression showed that septic shock was associated with tracheal injury scores (β: 2.99; 95% CI 0.70 to 5.29). Subgroup analysis revealed a stronger association with a duration of intubation ≥8 days (p=0.013).

Conclusion

Patients with septic shock exhibit significantly higher tracheal injury scores compared with those without septic shock, suggesting that septic shock may serve as an independent risk factor for tracheal injury.

Trial registration number

ChiCTR2000037842, registered 03 September 2020. Retrospectively registered, https://www.chictr.org.cn/edit.aspx?pid=57011&htm=4.

Understanding associations between the COVID-19 pandemic and menstrual hygiene management among adolescent girls in Ethiopia: findings from a mixed-methods longitudinal study

Por: Murphy · M. · Dutton · R. · Gezahegne · K. · Jones · N. · Seager · J. · Baird · S.
Objective

To understand the relationship between the COVID-19 pandemic and menstrual hygiene management (MHM) among adolescent girls in Ethiopia and to explore which girls were most affected by pandemic disruptions.

Design

Two rounds of data from surveys and interviews were collected with adolescent girls immediately prior to and during the COVID-19 pandemic. The primary analysis is cross-sectional, controlling for pre-COVID-19 covariates.

Setting

The setting was three zones in two regions of Ethiopia: East Hararghe and East Shewa Zones in Oromia and South Gondar Zone in Amhara. Data were collected in December 2019–March 2020 and September 2020–February 2021.

Participants

742 adolescent girls, ages 11–25 years.

Outcome measures

Four primary outcomes were explored (1) the number of challenges girls experienced; (2) adolescent-identified challenges managing menstrual hygiene; (3) adolescent-identified difficulties accessing MHM products and (4) adolescent-identified difficulties accessing soap or water.

Results

Girls who were more vulnerable to COVID-19 were more likely to have worse MHM outcomes. An SD increase in household vulnerability to COVID-19 was associated with an 8.7 percentage point increase in the likelihood that the respondent had difficulty getting MHM products (p

Conclusions

The results of this study suggest that MHM was left behind in the COVID-19 response. New programming and policy interventions need to address financial hardship and disruptions to supplies to manage menstruation as well as tackle the inequitable gender norms that stigmatise menstruation during emergencies.

Patient, caregiver and other knowledge user engagement in consensus-building healthcare initiatives: a scoping review protocol

Por: Munce · S. E. P. · Wong · E. · Luong · D. · Rao · J. · Cunningham · J. · Bailey · K. · John · T. · Barber · C. · Batthish · M. · Chambers · K. · Cleverley · K. · Crabtree · M. · Diaz · S. · Dimitropoulos · G. · Gorter · J. W. · Grahovac · D. · Grimes · R. · Guttman · B. · Hebert · M. L. · He
Introduction

Patient engagement and integrated knowledge translation (iKT) processes improve health outcomes and care experiences through meaningful partnerships in consensus-building initiatives and research. Consensus-building is essential for engaging a diverse group of experienced knowledge users in co-developing and supporting a solution where none readily exists or is less optimal. Patients and caregivers provide invaluable insights for building consensus in decision-making around healthcare, policy and research. However, despite emerging evidence, patient engagement remains sparse within consensus-building initiatives. Specifically, our research has identified a lack of opportunity for youth living with chronic health conditions and their caregivers to participate in developing consensus on indicators/benchmarks for transition into adult care. To bridge this gap and inform our consensus-building approach with youth/caregivers, this scoping review will synthesise the extent of the literature on patient and other knowledge user engagement in consensus-building healthcare initiatives.

Methods and analysis

Following the scoping review methodology from Joanna Briggs Institute, published literature will be searched in MEDLINE, EMBASE, CINAHL and PsycINFO databases from inception to July 2023. Grey literature will be hand-searched. Two independent reviewers will determine the eligibility of articles in a two-stage process, with disagreements resolved by a third reviewer. Included studies must be consensus-building studies within the healthcare context that involve patient engagement strategies. Data from eligible studies will be extracted and charted on a standardised form. Abstracted data will be analysed quantitatively and descriptively, according to specific consensus methodologies, and patient engagement models and/or strategies.

Ethics and dissemination

Ethics approval is not required for this scoping review protocol. The review process and findings will be shared with and informed by relevant knowledge users. Dissemination of findings will also include peer-reviewed publications and conference presentations. The results will offer new insights for supporting patient engagement in consensus-building healthcare initiatives.

Protocol registration

https://osf.io/beqjr

Comprehensive observational study evaluating the enduring effectiveness of 4CMenB, the meningococcal B vaccine against gonococcal infections in the Northern Territory and South Australia, Australia: study protocol

Por: Marshall · H. · Ward · J. · Wang · B. · Andraweera · P. · McMillan · M. · Flood · L. · Bell · C. · Sisnowski · J. · Krause · V. · Webby · R. · Childs · E. · Gunathilake · M. · Egoroff · N. · Leong · L. · Lawrence · A. · Baird · R. · Freeman · K. · Menouhos · D. · Whiley · D. M. · Karnon · J.
Introduction

The effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that the licensed meningococcal B (MenB) vaccine, 4CMenB is effective against gonococcal infections due to cross-reacting antibodies and 95% genetic homology between the two bacteria, Neisseria meningitidis and Neisseria gonorrhoeae, that cause the diseases. This project aims to undertake epidemiological and genomic surveillance to evaluate the long-term protection of the 4CMenB vaccine against gonococcal infections in the Northern Territory (NT) and South Australia (SA), and to determine the potential benefit of a booster vaccine doses to provide longer-term protection against gonococcal infections.

Methods and analyses

This observational study will provide long-term evaluation results of the effectiveness of the 4CMenB vaccine against gonococcal infections at 4–7 years post 4CMenB programme implementation. Routine notifiable disease notifications will be the basis for assessing the impact of the vaccine on gonococcal infections. Pathology laboratories will provide data on the number and percentage of N. gonorrhoeae positive tests relative to all tests administered and will coordinate molecular sequencing for isolates. Genome sequencing results will be provided by SA Pathology and Territory Pathology/New South Wales Health Pathology, and linked with notification data by SA Health and NT Health. There are limitations in observational studies including the potential for confounding. Confounders will be analysed separately for each outcome/comparison.

Ethics and dissemination

The protocol and all study documents have been reviewed and approved by the SA Department for Health and Well-being Human Research Ethics Committee (HREC/2022/HRE00308), and the evaluation will commence in the NT on receipt of approval from the NT Health and Menzies School of Health Research Human Research Ethics Committee. Results will be published in peer-reviewed journals and presented at scientific meetings and public forums.

Acute watery diarrhoea cases during cholera outbreak in Syria: a cohort study

Por: Arnaout · A. Y. · Nerabani · Y. · Sawas · M. N. · Alhejazi · T. J. · Farho · M. A. · Arnaout · K. · Alshaker · H. · Shebli · B. · Helou · M. · Mobaied · B. B. · Mouti · M. B. · Kady · F. · Aljarad · Z. · Aleppo University Hospital Team · shalabi · Dasouki · Breij · Shheibar · Alabdull
Objectives

The aim of this study is a descriptive presentation of cases of acute watery diarrhoea (AWD) that were presented to Aleppo University Hospital (AUH) during the recent cholera outbreak in Syria.

Design

Prospective, observational, cohort study.

Setting and participants

A total of 1061 patients with AWD were admitted to AUH during the timeframe of 20 September 2022 to 20 October 2022. The data collection was done through a structured questionnaire. This includes comprehensive clinical observation, laboratory analyses, therapeutic interventions and holistic case evaluations.

Results

The analysis has revealed notable insights: a predominant proportion of patients (58.6%) were residents from urban areas and 40.3% were residents from rural areas. Intriguingly, a diverse range of potential infection sources emerged from patient data within our hospital, including uncontrolled well water, vegetables and faecal-oral transmission through contaminated street/fast food. At discharge, most patients were in good health (79.7%), followed by moderate health (17.6%) and poor health (2.3%), with a minimal percentage dying before discharge (0.4%). The most common complications reported at admission and during hospitalisation included electrolyte imbalance (28.2%), followed by severe dehydration (16.3%). In the follow-up period, the majority of patients exhibited good health (81.0%). Older patients (>60 years) had poorer outcomes, with 8.4% having poor health and 4.2% death rate.

Conclusions

The study found results consistent with previous AWD outbreaks in developing countries like Yemen, Nigeria and Lebanon. Preventative measures like improving water sanitation and hygiene practices are essential to prevent future outbreaks and ease the strain on healthcare systems. Therefore, future studies must investigate the risk factors that increase the spread and the severity of the disease and investigate the best management method.

Cost analysis for initiating an integrated package of essential non-communicable disease interventions (PEN-Plus) in Kondoa District Hospital, Tanzania: a time-driven activity-based costing (TDABC) study protocol

Por: Ndumwa · H. P. · Mori · A. T. · Ruhago · G. M. · Willilo · R. · McBain · R. · Boudreaux · C. · Wroe · E. · Adler · A. J. · Bukhman · G. · Mayige · M. T. · Kaarboe · O.
Introduction

Non-communicable diseases (NCDs) constitute approximately 74% of global mortality, with 77% of these deaths occurring in low-income and middle-income countries. Tanzania exemplifies this situation, as the percentage of total disability-adjusted life years attributed to NCDs has doubled over the past 30 years, from 18% to 36%. To mitigate the escalating burden of severe NCDs, the Tanzanian government, in collaboration with local and international partners, seeks to extend the integrated package of essential interventions for severe NCDs (PEN-Plus) to district-level facilities, thereby improving accessibility. This study aims to estimate the cost of initiating PEN-Plus for rheumatic heart disease, sickle cell disease and type 1 diabetes at Kondoa district hospital in Tanzania.

Methods and analysis

We will employ time-driven activity-based costing (TDABC) to quantify the capacity cost rates (CCR), and capital and recurrent costs associated with the implementation of PEN-Plus. Data on resource consumption will be collected through direct observations and interviews with nurses, the medical officer in charge and the heads of laboratory and pharmacy units/departments. Data on contact times for targeted NCDs will be collected by observing a sample of patients as they move through the care delivery pathway. Data cleaning and analysis will be done using Microsoft Excel.

Ethics and dissemination

Ethical approval to conduct the study has been waived by the Norwegian Regional Ethics Committee and was granted by the Tanzanian National Health Research Ethics Committee NIMR/HQ/R.8a/Vol.IX/4475. A written informed consent will be provided to the study participants. This protocol has been disseminated in the Bergen Centre for Ethics and Priority Setting International Symposium, Norway and the 11th Muhimbili University of Health and Allied Sciences Scientific Conference, Tanzania in 2023. The findings will be published in peer-reviewed journals for use by the academic community, researchers and health practitioners.

Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions

Por: Gumber · L. · Agbeleye · O. · Inskip · A. · Fairbairn · R. · Still · M. · Ouma · L. · Lozano-Kuehne · J. · Bardgett · M. · Isaacs · J. D. · Wason · J. M. · Craig · D. · Pratt · A. G.
Objective

International trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. The aim of this systematic review was to identify the operational complexities of conducting international trials and identify potential solutions for overcoming them.

Design

Systematic review.

Data sources

Medline, Embase and Health Management Information Consortium were searched from 2006 to 30 January 2023.

Eligibility criteria

All studies reporting operational challenges (eg, site selection, trial management, intervention management, data management) of conducting international trials were included.

Data extraction and synthesis

Search results were independently screened by at least two reviewers and data were extracted into a proforma.

Results

38 studies (35 RCTs, 2 reports and 1 qualitative study) fulfilled the inclusion criteria. The median sample size was 1202 (IQR 332–4056) and median number of sites was 40 (IQR 13–78). 88.6% of studies had an academic sponsor and 80% were funded through government sources. Operational complexities were particularly reported during trial set-up due to lack of harmonisation in regulatory approvals and in relation to sponsorship structure, with associated budgetary impacts. Additional challenges included site selection, staff training, lengthy contract negotiations, site monitoring, communication, trial oversight, recruitment, data management, drug procurement and distribution, pharmacy involvement and biospecimen processing and transport.

Conclusions

International collaborative trials are valuable in cases where recruitment may be difficult, diversifying participation and applicability. However, multiple operational and regulatory challenges are encountered when implementing a trial in multiple countries. Careful planning and communication between trials units and investigators, with an emphasis on establishing adequately resourced cross-border sponsorship structures and regulatory approvals, may help to overcome these barriers and realise the benefits of the approach.

Open science framework registration number

osf-registrations-yvtjb-v1.

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.
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.

Disparities in awareness and utilisation of National Essential Public Health Services between the floating population and the registered residents: a cross-sectional study in China

Por: Wang · J. · Bai · L. · Xu · X.
Objective

There are differences between the floating population and the registered population in the awareness and use of the National Essential Public Health Services (NEPHS) due to the influence of China’s household registration system. The Equalization of Basic Public Health and Family Planning Services (EBPHFPS) policy aims to reduce disparities among populations by enhancing the migrant population’s access to basic public health services. The aim of this study is to examine the relationship between the EBPHFPS targeted at the floating population and the disparities in access to and utilisation of NEPHS between registered residents and the floating population.

Design

A cross-sectional study.

Setting

8 cities (regions, autonomous prefectures) in China.

Participants

13 998 floating population and 14 000 registered residents in eight cities (regions, autonomous prefectures) were included in the analysis.

Outcome measures

Three binomial variables, including awareness of NEPHS, acceptance of health education and establishment of health records, were used as outcome indicators to examine the relationship between the EBPHFPS and the disparities between the floating and registered populations.

Methods

A linear regression model, fairness gap calculation and propensity score matching were used to explore the associations.

Results

The areas that implemented EBPHFPS exhibited an 8.3% increase in awareness of the NEPHS (p0.1). The floating population in the pilot areas of the policy encountered greater disparities in the establishment of health records (p

Conclusions

Positive associations between the EBPHFPS policy and NEPHS awareness and utilisation among the floating population were demonstrated to some extent; however, the floating population was still confronted with a degree of inequality of opportunity. The government needs to develop target-oriented policies and a guaranteed mechanism to ensure access to NEPHS among the floating population.

Alcohol use among in-school adolescents in Sierra Leone

Por: Osborne · A. · Aboagye · R. G. · Olorunsaiye · C. Z. · James · P. B. · Bangura · C. · Seidu · A.-A. · Kangbai · J. B. · Ahinkorah · B. O.
Objective

To examine the prevalence of alcohol use and its associated factors among in-school adolescents in Sierra Leone.

Design

Data for the study was sourced from the 2017 Sierra Leone Global School-Based Student Health Survey, a nationally representative survey conducted among in-school adolescents aged 10–19 years using a multistage sampling methodology. Percentages were used to present the prevalence of alcohol use among in-school adolescents. Multivariable binary logistic regression analysis was performed to examine the factors associated with alcohol use among in-school adolescents. The results were presented using adjusted odds ratios (aOR) with their respective 95% confidence interval (CI).

Setting

Sierra Leone.

Participants

A weighted sample of 1730 in-school adolescents in Sierra Leone.

Outcome measure

Current alcohol use.

Results

The prevalence of alcohol use among in-school adolescents was 10.7% (7.3, 15.3). In-school adolescents in senior secondary schools were more likely to use alcohol compared with those in junior secondary school (aOR=2.13; 95% CI 1.37, 3.30). The odds of alcohol use was higher among in-school adolescents who were truant at school relative to those who were not (aOR=2.24; 95% CI 1.54, 3.26). Also, in-school adolescents who were bullied (aOR=1.85; 95% CI 1.24, 2.76), ever engaged in sexual intercourse (aOR=2.06; 95% CI 1.39, 3.06), and used marijuana (aOR=3.36; 95% CI 1.72, 6.53) were more likely to use alcohol compared with those who were not. However, in-school adolescents who reported that their parents understood their problems (aOR=0.52; 95% CI 0.33, 0.82) had a lower likelihood of consuming alcohol.

Conclusion

Our study has shown that alcohol use is prevalent among in-school adolescents in Sierra Leone. Grade level, experiences of being bullied, history of sexual intercourse, truancy at school, and previous use of marijuana were the factors influencing alcohol use among in-school adolescents. The findings emphasise the necessity of creating school-based health interventions in Sierra Leone that can effectively identify in-school adolescents potentially vulnerable to alcohol-related issues. Also, existing policies and programmes aimed at reducing alcohol use among in-school adolescents need to be strengthened.

What Matters to Aboriginal and Torres Strait Islander Youth (WM2Y): a study protocol to develop a national youth well-being measure

Por: Garvey · G. · Howard · K. · Garvey · D. · Dickson · M. · Howell · M. · Butler · T. L. · Cadet-James · Y. · Cunningham · J. · Bainbridge · R. · McGorry · P. · Williamson · A. · Anderson · K. M.
Introduction

Adolescents face challenges associated with unprecedented environmental, social and technological changes. The impacts of colonisation, intergenerational trauma, racism and socioeconomic disadvantage intensify these challenges for many Aboriginal and Torres Strait Islander adolescents. However, Aboriginal and Torres Strait Islander adolescents also have cultural, spiritual, family and community capital that fosters their well-being.

To date, little research has focused on understanding and appropriately measuring the well-being of Aboriginal and Torres Strait Islander adolescents, a pivotal factor in informing and guiding programmes and interventions that support them. This study will identify the domains of well-being and develop a new preference-based well-being measure based on the values and preferences of Aboriginal and Torres Strait Islander youth (aged 12–17 years).

Methods and analysis

This project will be conducted across three research phases: (1) qualitative exploration of well-being using PhotoYarning and yarns with adult mentors to develop candidate items; (2) Think Aloud study, quantitative survey, psychometric analysis, validity testing of candidate items and finalisation of the descriptive system; and (3) scoring development using a quantitative preference-based approach. A multinomial (conditional) logit framework will be used to analyse responses and generate a scoring algorithm for the new preference-based well-being measure.

Ethics and dissemination

Ethics approvals have been obtained from: the Human Research Ethics Committees for each state and territory where data are being collected, the institutions where the research is being conducted and from the relevant Departments of Education. The new well-being measure will have wide applicability and can be used in assessing the effectiveness of programmes and services. This new national measure will ensure benefit and positive impact through the ability to identify and measure the aspects of well-being important to and valued by Aboriginal and Torres Strait Islander youth. Results will be published in international peer-reviewed journals and presented at conferences, and summaries will be provided to the study partner organisations and other relevant organisations.

Prevalence and predictors of lifetime amphetamine use among in-school adolescents in Sierra Leone.

Por: Osborne · A. · Aboagye · R. G. · Olorunsaiye · C. Z. · James · P. B. · Bangura · C. · Seidu · A.-A. · Kangbai · J. B. · Ahinkorah · B. O.
Objective

This study examined the prevalence of amphetamine use and its associated factors among in-school adolescents in Sierra Leone.

Design

Data for the study was sourced from the 2017 Sierra Leone Global School-based Health Survey. Percentages with confidence intervals (CIs) were used to present the prevalence of amphetamine use among in-school adolescents. A multivariable binary logistic regression analysis was employed to examine the factors associated with amphetamine use. The results were presented using adjusted odds ratios (aORs) with 95% CIs.

Setting

Sierra Leone.

Participants

A weighted sample of 1,314 in-school adolescents in Sierra Leone.

Outcome measure

Lifetime amphetamine use.

Results

The prevalence of amphetamine use was 6.1% (3.9%–9.5%). In-school adolescents who planned suicide were more likely to use amphetamine compared with those who did not (aOR 2.54; 95% CI 1.02 to 6.31). Also, the odds of amphetamine use were higher among in-school adolescents who received support from their peers (aOR 3.19, 95% CI 1.71 to 5.96), consumed alcohol (aOR 4.85, 95% CI 2.61 to 9.03), and those who had previously used marijuana (aOR 13.31, 95% CI 6.61 to 28.78) compared with those who did not receive any support, never consumed alcohol, and never used marijuana, respectively.

Conclusion

Amphetamine use is prevalent among in-school adolescents in Sierra Leone. There is a need to implement comprehensive public health policies that extend beyond school-based psychobehavioural therapies. These policies should specifically address the considerable risk factors associated with amphetamine use among in-school adolescents in Sierra Leone.

Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) - protocol for a multi-centre open-label randomised trial

Por: Hudson · E. M. · Noutch · S. · Webster · J. · Brown · S. R. · Boele · F. W. · Al-Salihi · O. · Baines · H. · Bulbeck · H. · Currie · S. · Fernandez · S. · Hughes · J. · Lilley · J. · Smith · A. · Parbutt · C. · Slevin · F. · Short · S. · Sebag-Montefiore · D. · Murray · L.
Introduction

Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain health-related quality of life (HRQoL). Chemotherapy is typically employed for recurrent GBM, often using nitrosourea-based regimens. However, efficacy is limited, with reported median survivals between 5 and 9 months from recurrence. Although less commonly used in the UK, there is growing evidence that re-irradiation may produce survival outcomes at least similar to nitrosourea-based chemotherapy. However, there remains uncertainty as to the optimum approach and there is a paucity of available data, especially with regards to HRQoL. Brain Re-Irradiation Or Chemotherapy (BRIOChe) aims to assess re-irradiation, as an acceptable treatment option for recurrent IDH-wild-type GBM.

Methods and analysis

BRIOChe is a phase II, multi-centre, open-label, randomised trial in patients with recurrent GBM. The trial uses Sargent’s three-outcome design and will recruit approximately 55 participants from 10 to 15 UK radiotherapy sites, allocated (2:1) to receive re-irradiation (35 Gy in 10 daily fractions) or nitrosourea-based chemotherapy (up to six, 6-weekly cycles). The primary endpoint is overall survival rate for re-irradiation patients at 9 months. There will be no formal statistical comparison between treatment arms for the decision-making primary analysis. The chemotherapy arm will be used for calibration purposes, to collect concurrent data to aid interpretation of results. Secondary outcomes include HRQoL, dexamethasone requirement, anti-epileptic drug requirement, radiological response, treatment compliance, acute and late toxicities, progression-free survival.

Ethics and dissemination

BRIOChe obtained ethical approval from Office for Research Ethics Committees Northern Ireland (reference no. 20/NI/0070). Final trial results will be published in peer-reviewed journals and adhere to the ICMJE guidelines.

Trial registration number

ISRCTN60524.

University staff perspectives on determinants of high-quality health professions student placements in regional, rural and remote Australia: protocol for a mixed-method study

Por: Quilliam · C. · Green · E. · Rasiah · R. L. · Sheepway · L. · Seaton · C. · Moore · L. · Bailie · J. · Matthews · K. M. · Ferns · J. · Debenham · J. · Taylor · C. · Fitzgerald · K. · Ridd · M.
Introduction

In rural areas, work-integrated learning in the form of health student placements has several potential benefits, including contributing to student learning, enhancing rural health service capacity and attracting future rural health workforce. Understanding what constitutes a high-quality rural placement experience is important for enhancing these outcomes. There is no current standardised definition of quality in the context of rural health placements, nor is there understanding of how this can be achieved across different rural contexts. This study is guided by one broad research question: what do university staff believe are the determinants of high-quality health professions student placements in regional, rural and remote Australia?

Methods and analysis

This study will adopt a convergent mixed-method design with two components. Component A will use explanatory sequential mixed methods. The first phase of component A will use a survey to explore determinants that contribute to the development of high-quality health student placements from the perspective of university staff who are not employed in University Departments of Rural Health and are involved in the delivery of health student education. The second phase will use semistructured interviews with the same stakeholder group (non-University Department of Rural Health university staff) to identify the determinants of high-quality health student placements. Component B will use a case study Employing COnceptUal schema for policy and Translation Engagement in Research mind mapping method to capture determinants that contribute to the development of high-quality health student placements from the perspective of University Department of Rural Health university staff.

Ethics and dissemination

The University of Melbourne Human Ethics Committee approved the study (2022-23201-33373-5). Following this, seven other Australian university human research ethics committees provided external approval to conduct the study. The results of the study will be presented in several peer-review publications and summary reports to key stakeholder groups.

Sociological determinants of adherence to continuous positive airway pressure in the management of sleep apnoea syndrome: protocol for a transdisciplinary, prospective observational study

Por: Bailly · S. · Foote · A. · Mendelson · M. · Rakotovao · A. · Borel · J. C. · Pepin · J. L. · Tamisier · R. · Revil · H.
Introduction

Obstructive sleep apnoea syndrome (OSAS) is a chronic multiorgan pathology that has a negative impact on quality of life. Continuous positive airway pressure (CPAP) is the first-line treatment for OSAS. However, CPAP termination rates remain very high, and adherence to therapy is a major issue. To date, studies targeting predictive factors of CPAP adherence by OSAS patients mainly include clinical data. The social, socioeconomic, psychological, and home environment aspects have been far less studied and largely underestimated. This study aims to obtain solid quantitative results examining the relationship between the determinants of refusal, non-adherence, or termination of CPAP treatment, and in particular the pivotal role played by health literacy.

Methods and analysis

This is a prospective, multicentre, observational study recruiting patients attending the sleep clinic of the Grenoble Alpes University Hospital, France. Consecutive adults (>18 years) recently diagnosed with OSAS and prescribed CPAP treatment with telemonitoring will be enrolled in the present study. They will benefit from home visits by a CPAP technician or nurse at CPAP initiation. Patients will then be followed up for 6 months through the telemonitoring platform of a home-care provider. The primary objective is to evaluate the impact of health literacy (health literacy, measured by the European Health Literacy Survey questionnaire (HLS-EU-16) on the refusal, non-adherence or termination of CPAP treatment in newly diagnosed OSAS patients, during the first 6 months after diagnosis. The target sample size is 250 participants.

Ethics and dissemination

The study protocol, patient information, and the non-opposition form were approved by the French national ethics committee (CPP 2021-92, January 2022). All patients are required to have signed a written informed consent form permitting their anonymised personal and medical data to be used for clinical research purposes. We will publish the results in a peer-reviewed medical journal and on our institutional websites.

Trial registration number

NCT05385302.

Adaptive coping strategies among individuals living with long-term chikungunya disease: a qualitative study in Curacao

Por: Doran · C. · Duits · A. J. · Gerstenbluth · I. · Tami · A. · Bailey · A.
Objective

Long-term chikungunya disease is characterised by persistent rheumatic symptoms following chikungunya virus infection. As there is no specific treatment available, affected individuals need strategies to adapt. However, research on these is scarce. This study aimed to explore which adaptive coping strategies are employed to manage persistent rheumatic symptoms in daily life.

Setting

The study was conducted in Curacao.

Design and participants

An explorative qualitative study was conducted between September and October 2020, among a purposive sample of adults, 19 women and 4 men affected by long-term chikungunya disease. In-depth interviews were semi-structured and transcribed verbatim. The data were analysed using inductive thematic analysis.

Results

The disease duration for all participants ranged between 68 and 74 months (6 years). In narrating their experiences of coping with long-term chikungunya disease, four themes were identified: (1) learning to live with the disease; (2) resilience for dealing with pain; (3) maintaining positive self-image and attitude; and (4) coping through spirituality.

Conclusion

To live with long-term chikungunya disease with dignity in spite of physical pain and discomfort, participants tried to retain a sense of control of oneself and one’s lives, to not let the disease take over, focusing on the positive in their lives, and finding strength and remain hopeful. Interventions such as cognitive–behavioural therapy and mindfulness exercises may be effective in strengthening or regain affected individual’s sense of competence and control by fostering adaptive coping skills and resilience. Subsequently, these interventions may improve health-related quality of life when rheumatic symptoms persist following chikungunya virus infection.

Priming transcranial direct current stimulation for improving hemiparetic upper limb in patients with subacute stroke: study protocol for a randomised controlled trial

Por: Zhu · F. · Xu · X. · Jin · M. · Chen · J. · Feng · X. · Wang · J. · Yu · D. · Wang · R. · Lian · Y. · Huai · B. · Lou · X. · Shi · X. · He · T. · Lu · J. · Zhang · J. J. · Bai · Z.
Introduction

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that modulates brain states by applying a weak electrical current to the brain cortex. Several studies have shown that anodal stimulation of the ipsilesional primary motor cortex (M1) may promote motor recovery of the affected upper limb in patients with stroke; however, a high-level clinical recommendation cannot be drawn in view of inconsistent findings. A priming brain stimulation protocol has been proposed to induce stable modulatory effects, in which an inhibitory stimulation is applied prior to excitatory stimulation to a brain area. Our recent work showed that priming theta burst magnetic stimulation demonstrated superior effects in improving upper limb motor function and neurophysiological outcomes. However, it remains unknown whether pairing a session of cathodal tDCS with a session of anodal tDCS will also capitalise on its therapeutic effects.

Methods and analysis

This will be a two-arm double-blind randomised controlled trial involving 134 patients 1–6 months after stroke onset. Eligible participants will be randomly allocated to receive 10 sessions of priming tDCS+robotic training, or 10 sessions of non-priming tDCS+robotic training for 2 weeks. The primary outcome is the Fugl-Meyer Assessment-upper extremity, and the secondary outcomes are the Wolf Motor Function Test and Modified Barthel Index. The motor-evoked potentials, regional oxyhaemoglobin level and resting-state functional connectivity between the bilateral M1 will be acquired and analysed to investigate the effects of priming tDCS on neuroplasticity.

Ethics and dissemination

The study has been approved by the Research Ethics Committee of the Shanghai Yangzhi Rehabilitation Center (reference number: Yangzhi2023-022) and will be conducted in accordance with the Declaration of Helsinki of 1964, as revised in 2013.

Trial registration number

ChiCTR2300074681.

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).

Assessing the impact of diverse mask types on COPD patients: a randomised controlled trial study protocol

Por: Chen · X. · Jiang · X. · Zhang · X. · Ren · D. · Wei · C. · Xu · A. · Yang · H. · Bai · R. · Li · C. · Yue · F. · Bao · S. · Shi · J. · Fan · J.
Introduction

Wearing masks has proven beneficial in preventing respiratory pathogen infections in individuals with chronic obstructive pulmonary disease (COPD). However, the impact of different mask types on physiological indicators and daily physical activity in COPD patients remains uncertain. This study aims to assess the immediate effects of various mask types on cardiopulmonary function indicators, subjective perceptions and the 6-minute walking distance (6MWD) in individuals with COPD.

Methods and analysis

This randomised controlled trial will enrol 129 stable COPD patients. Participants will be randomly divided into three groups: control, N95 mask and surgical mask groups. Each group will undergo both a 6-minute seated test and a 6-minute walk test (6MWT), without or with their respective masks. A 10-minute interval will be provided between the two phases. The primary indicators of the study include the 6MWD and blood oxygen saturation. Secondary outcomes encompass blood pressure, pulse rate, Borg score, Rate of Perceived Exertion (RPE) score and subjective perception score. Oxygen saturation, pulse rate and blood pressure will be recorded four times during the trial, while Borg and RPE scores will be compared before and after the 6MWT. Additionally, subjective perception scores will be collected after each mask-wearing stage.

Ethics and dissemination

This study has received approval from the Ethics Committee of the Affiliated Hospital of Gansu University of Chinese Medicine (approval number: 202335). We plan to disseminate research results through publication in a peer-reviewed journal or presentation at a conference.

Trial registration number

ChiCTR2300074554.

Service readiness for the management of non-communicable diseases in publicly financed facilities in Malawi: findings from the 2019 Harmonised Health Facility Assessment census survey

Por: Ahmed · S. · Cao · Y. · Wang · Z. · Coates · M. M. · Twea · P. · Ma · M. · Chiwanda Banda · J. · Wroe · E. · Bai · L. · Watkins · D. A. · Su · Y.
Introduction

Non-communicable diseases (NCDs) are rising in low-income and middle-income countries, including Malawi. To inform policy-makers and planners on the preparedness of the Malawian healthcare system to respond to NCDs, we estimated NCD service readiness in publicly financed healthcare facilities in Malawi.

Methods

We analysed data from 564 facilities surveyed in the 2019 Harmonised Health Facility Assessment, including 512 primary healthcare (PHC) and 52 secondary and tertiary care (STC) facilities. To characterise service readiness, applying the law of minimum, we estimated the percentage of facilities with functional equipment and unexpired medicines required to provide NCD services. Further, we estimated permanently unavailable items to identify service readiness bottlenecks.

Results

Fewer than 40% of PHC facilities were ready to deliver services for each of the 14 NCDs analysed. Insulin and beclomethasone inhalers had the lowest stock levels at PHC facilities (6% and 8%, respectively). Only 17% of rural and community hospitals (RCHs) have liver and kidney diagnostics. STC facilities had varying service readiness, ranging from 27% for managing acute diabetes complications to 94% for chronic type 2 diabetes management. Only 38% of STC facilities were ready to manage chronic heart failure. Oral pain medicines were widely available at all levels of health facilities; however, only 22% of RCHs and 29% of STCs had injectable morphine or pethidine. Beclomethasone was never available at 74% of PHC and 29% of STC facilities.

Conclusion

Publicly financed facilities in Malawi are generally unprepared to provide NCD services, especially at the PHC level. Targeted investments in PHC can substantially improve service readiness for chronic NCD conditions in local communities and enable STC to respond to acute NCD complications and more complex NCD cases.

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