FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Surgery or radiotherapy for early-stage cancer study protocol for an emulated target trial of radical radiotherapy versus radical cystectomy, with either following neoadjuvant chemotherapy, for organ-confined muscle-invasive bladder cancer

Por: Kagenaar · E. · Lugo-Palacios · D. G. · Bromley · H. · Aggarwal · A. · Hutchings · A. · ONeill · S. · Rachet · B. · Cresswell · J. · Choudhury · A. · Grieve · R.
Introduction

Neoadjuvant chemotherapy (NAC) followed by definitive treatment consisting of either radical radiotherapy or radical cystectomy is the recommended treatment for patients with organ-confined muscle-invasive bladder cancer (OC-MIBC). A randomised controlled trial (RCT) aimed to compare the effectiveness of radical radiotherapy and radical cystectomy but failed to recruit. Radical radiotherapy is non-invasive and organ-preserving, and observational studies have suggested this treatment may be associated with similar outcomes compared with radical cystectomy. However, in these observational studies, the risk of confounding was high, and they did not consider the receipt of NAC. The surgery or radiotherapy (SORT) for the early-stage cancer study will assess the comparative effectiveness and cost-effectiveness of either radical cystectomy or radical radiotherapy, both after NAC for OC-MIBC. We will use a target trial emulation approach to reduce the risk of bias when assessing comparative effectiveness from observational data.

Methods and analysis

The SORT study will use UK’s National Cancer Registry to identify individuals diagnosed with urothelial OC-MIBC (T2-4aN0M0) between 1 January 2015 and 31 December 2021 who received either radical radiotherapy or radical cystectomy after NAC. The data will be linked to Hospital Episode Statistics (HES), National Radiotherapy Data Set (RTDS) and Systemic Anti-Cancer Therapy (SACT) data sets to gather information on clinical, tumour and socio-demographic characteristics and receipt of treatment. Using the target trial emulation framework, we will define the eligibility criteria and radical radiotherapy and radical cystectomy receipt. To reduce the risk of confounding, we will use advanced statistical approaches to allow for differences in measured baseline characteristics between the comparison groups.

The primary outcome is 3-year all-cause mortality after radical treatment receipt. Secondary outcomes will include all-cause and bladder-cancer-associated mortality at 3 and 5 years, time to death, incremental costs and incremental cost-effectiveness reported according to net health benefits.

Ethics and dissemination

The study was approved by the London School of Hygiene and Tropical Medicine Ethics Committee (Reference number 29717 - 1). Results will be communicated in open-access journals and conferences to clinicians, researchers, patients and policymakers.

Sustaining community self-help groups beyond donor support: lessons from a qualitative study of self-help groups, including persons affected by leprosy and disability in rural India

Por: Darlong · J. · Charles · M. V. · Ilozumba · O. · Govindasamy · K. · Shrivastva · A. · Choudhury · S. · Sartori · J. · Lindenmeyer · A. · Lilford · R. J. · Griffiths · F.
Introduction

Leprosy remains a significant public health challenge in many low and middle-income countries, including India. People affected by leprosy face multifaceted challenges: physical, psychological, social and economic. In response, donors support self-help groups (SHGs) to improve health, social integration and economic circumstances for marginalised people, including those with leprosy. This study aims to assess the sustainability of SHGs in India after the withdrawal of donor support by examining whether they remain functional and exploring the key factors, barriers and facilitators that influence their long-term social and economic viability.

Objectives

To examine the functionality of SHGs after withdrawal of donor support, and to explore the factors, barriers and facilitators influencing their long-term social and economic sustainability.

Methods

Using qualitative methods, we conducted semistructured interviews with 40 key informants associated with five SHGs formed under the Self-Help Community Development Project implemented in an endemic state of India and funded by The Leprosy Mission Trust India.

Study design

It was an exploratory qualitative study using interviews with SHG members and key informants, situated within the self-help community-based project.

Results

While some SHGs demonstrated resilience and adaptability, others faced challenges such as internal discord, loss of members to migration and lack of access to government schemes. Thematic analysis revealed key drivers and barriers to sustainability and realising the benefits of SHGs, highlighting variations in leadership, governance, economic performance and social engagement across groups.

Discussion and conclusion

SHGs are often sustained after the funding and managerial donor support have been withdrawn. The findings emphasise the importance of strong leadership, community support and external facilitation in sustaining SHGs and enhancing their impact on marginalised populations. This study contributes to understanding the role of SHGs in addressing the socioeconomic challenges faced by individuals affected by leprosy and offers insights for improving their long-term viability.

Weaning patients off long-term prednisolone: a survey of physicians practice in the UK and Southeast Asia

Por: Lazarus · K. · Eng · P. C. · Narula · K. · Sharma · A. · Choudhury · S. · Papadopoulou · D. · Martin · N. M. · Wernig · F. · Tan · T. · Meeran · K.
Study objective

Prolonged glucocorticoid (GC) use is associated with significant morbidity and mortality, including the development of GC induced adrenal insufficiency. Recent guidance from the European Society of Endocrinology and Endocrine Society provides a framework for tapering GCs. However, there is limited understanding of current practice across endocrine and other medical specialties, including barriers and challenges to GC weaning. This study aimed to establish how GCs are weaned in patients across endocrine and non-endocrine specialists.

Design and setting

Anonymous online surveys were disseminated to all members of the Society for Endocrinology and all members of the Association of Southeast Asian Nations Federation of Endocrine Societies and the Endocrine and Metabolic Society of Singapore. Non-endocrine specialists were surveyed in the UK and in Singapore.

Results

A total of 306 (258 endocrine specialists and 48 non-endocrine specialists) responded to the survey. Approaches to discontinuing prednisolone were heterogeneous. Among endocrine respondents, only 78% would fully wean the prednisolone, with 50.4% switching to hydrocortisone to wean and 12.6% favouring long-term GC replacement without further investigations. Among the non-endocrine respondents, 16.7% would stop prednisolone abruptly and 10.4% would refer to endocrinology to supervise weaning. The most common barrier to weaning GCs reported by both endocrine and non-endocrine specialists was relapse of the underlying condition (55.9% and 70.8%, respectively).

Conclusions

Relapse of the underlying condition is common, and endocrinology input may not be appropriate when this occurs. There remains a need to develop an evidence-based approach for safe and effective GC weaning and hypothalamic–pituitary–adrenal axis assessment.

Observational study on the clinical epidemiology of infectious acute encephalitis syndrome including Nipah virus disease, Bangladesh: BASE cohort study protocol

Por: Hassan · M. Z. · Rojek · A. · Rahman · D. I. · Sultana · S. · Rahman · M. · Khaja Mafij Uddin · M. · Hossain · M. E. · Rahman · M. W. · Merson · L. · Garcia · E. · Dunning · J. · Bourner · J. · Choudhury · S. S. · Chowdhury · K. I. A. · Zaman · K. · Khan · S. I. · Tarik · M. H. · Yeasmin
Introduction

Nipah virus (NiV) is a bat-transmitted paramyxovirus causing recurrent, high-mortality outbreaks in South and South-East Asia. As a WHO priority pathogen, efforts are underway to develop therapies like monoclonal antibodies and small-molecule antivirals, which require evaluation in clinical trials. However, trial design is challenging due to limited understanding of NiV’s clinical characteristics. Given the rarity of NiV infections, strategies targeting improved outcomes for the broader acute encephalitis syndrome (AES) patient population, including those with NiV, are essential for advancing therapeutic research. To address these gaps, we designed the Bangladesh AES cohort study to characterise the patient population, clinical features, treatment practices, common aetiologies and outcomes in patients presenting with AES, including NiV infection, as a clinical characterisation study to inform the design of clinical trials for NiV and AES more broadly.

Methods and analysis

This prospective cohort study will be conducted in Bangladesh, a NiV endemic country with annual outbreaks. In collaboration with the ongoing NiV surveillance programme in Bangladesh, we aim to enrol up to 2000 patients of all ages presenting with AES at three tertiary care hospitals within the Nipah belt. Patients who provide informed consent to participate will be monitored throughout their hospital stay until 90 days post enrolment. Data will be systematically collected through interviews and medical record reviews at several time points: on the day of enrolment, day 3, day 7, the day of critical care admission (if applicable), discharge day and 90 days post enrollment. Additionally, a portion of the cerebrospinal fluid collected under the concurrent NiV surveillance protocol will be tested for an array of viral and bacterial pathogens responsible for encephalitis at the International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b) laboratory.

Ethics and dissemination

The study received ethical approval from the Oxford Tropical Research Ethics Committee, University of Oxford, UK (OxTREC Ref: 576–23) and the institutional review board of icddr,b, Bangladesh (icddr,b protocol number: 24016). By characterising the AES patient population, this study will generate essential evidence on key clinical parameters, which will be pivotal in optimising the design of clinical trials for potential interventions aimed at improving outcomes in patients with AES, including those with NiV disease. Findings will be shared with participating hospitals, patients and relevant government stakeholders. Results will also be disseminated through conference presentations and peer-reviewed publications.

Clinical trial number

Not applicable (this is an observational study).

Surgery or radiotherapy for early-stage cancer study (SORT) target trial protocol: stereotactic ablative radiotherapy (SABR) with curative intent versus surgical resection for early-stage non-small cell lung cancer (NSCLC)

Por: Kagenaar · E. · Lugo-Palacios · D. G. · Hutchings · A. · Aggarwal · A. · ONeill · S. · Rachet · B. · Edwards · J. · Faivre-Finn · C. · Grieve · R. · Surgery or Radiotherapy Study (SORT) group · Choudhury · Vohra · Cresswell · Charlton · Chuter · Nolte · Gravenhorst · Alencar · Mon
Introduction

Randomised controlled trials have aimed to assess the effectiveness of stereotactic ablative radiotherapy (SABR) with curative intent versus surgical resection for individuals diagnosed with early-stage non-small cell lung cancer (NSCLC) but have failed to recruit sufficient numbers of patients. Non-randomised studies for early-stage NSCLC have reported mixed outcomes following curative SABR versus surgical resection, but did not fully address confounding by indication. The Surgery Or RadioTherapy for early-stage cancer study (SORT) will assess the comparative effectiveness of SABR with curative intent versus surgical resection for NSCLC with a target trial emulation approach, as this can reduce biases in observational studies that aim to estimate the causal effect of interventions.

Methods and analysis

The SORT study will use the National Cancer Registry for individuals diagnosed with early-stage NSCLC in England during 2015–2020 (inclusive) who received SABR with curative intent or surgical resection. These data will be linked to Hospital Episode Statistics, National Radiotherapy Data Set and the Systemic Anti-Cancer Therapy dataset to obtain information on clinical and sociodemographic characteristics and the treatment received. This target trial emulation will define study population eligibility criteria and regimens for SABR with curative intent and surgical resection. We will reduce the risk of residual confounding with instrumental variable analyses that will exploit geographical variation across the National Health Service in England in the use of SABR with curative intent versus surgical resection for early-stage NSCLC. The primary outcome will be 3-year all-cause mortality after treatment initiation. Secondary outcomes will include 3-month, 6-month, 12-month and 24-month all-cause and lung-cancer mortality, time to death, numbers of hospitalisations, incremental costs and incremental cost-effectiveness.

Ethics and dissemination

Ethical approval was obtained from the London School of Hygiene and Tropical Medicine Research Ethics Committee (reference number 29 717–1). Results will be disseminated to clinicians, patients, policy-makers and researchers.

❌