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Buccal fat applied to transoral robotic lateral oropharyngectomy defects to lessen radical tonsillectomy pain (BOLT): a single-centre, phase II, parallel, randomised control trial study protocol

Por: Xie · M. · de Almeida · J. · Goldstein · D. · Martino · R. · Liu · Y. F. · Allen · B. · Xu · W. · Hueniken · K. · Yao · C. M.
Introduction

Transoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction.

Methods and analysis

This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/–) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model.

Ethics and dissemination

The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals.

Trial registration number

NCT06965738.

Antibiotic stewardship in suspected neutropenic fever (ASTERIC trial): a multicentre, type 1 hybrid effectiveness-implementation, stepped-wedge, randomised controlled trial study protocol

Por: Rainer · T. H. · Lam · R. P. K. · Tsang · T. C. · Wai · A. K.-C. · Leung · S. C. · Leung · R. Y. Y. · Wong · C. K. H. · Gill · H. · Lam · W. W. T. · Wing Lok Chan · W. · Chi Kin Cheung · A. · Lau · M. T. · Lee · S. F. · Choi · Y. F. · Fong Lun Lee · H. · Mok · K. L. · Lam · H. C. · Lee
Introduction

Neutropenic fever (NF) has a crude mortality rate of 3–18%. International guidelines recommend that all patients with NF receive ultrabroad-spectrum antibiotics (UBSAs) within 1 hour of emergency department (ED) registration. However, over 70% patients presenting to hospital with suspected NF (sNF) cannot access absolute neutrophil count (ANC) result within 1 hour, do not have NF and do not require UBSAs. In ED and hospitalised patients with sNF, we hypothesise that the ASTERIC protocol effectively and safely reduces the use of UBSAs compared with standard care alone.

Methods and analysis

This pragmatic, parallel, multicentre, type 1, hybrid effectiveness-implementation, stepped-wedge, before-and-after, cluster randomised controlled trial aims to evaluate whether antibiotic prescribing can be safely reduced through implementing a multifaceted antibiotic stewardship intervention (ASTERIC) in adult patients with sNF presenting to EDs. The sNF was defined as a fever with a single oral temperature of ≥38.3°C (101°F) within 24 hours before ED registration or a temperature of ≥38.0°C (100.4°F) sustained over a 1-hour period, following last chemotherapy or targeted therapy within 6 weeks for any solid tumour, or in any period following therapies against leucaemia, lymphoma, myelodysplastic syndrome, aplastic anaemia, multiple myeloma or recipient of HSCT. The study will involve eight hospitals in Hong Kong with variable baseline practice. We will include 704 adult patients (352 patients in pre-implementation and post-implementation periods, respectively) with sNF (tympanic temperature ≥38.3°C) and 48 staff participants (6 staff participants in each hospital). Healthcare professionals will receive a multifaceted stewardship intervention consisting of risk assessment tools, fast-track ANCs, a decision tool for patient management and antibiotic use, supported by an educational package and staff interaction programmes (ASTERIC protocol). Patients’ blood ANC, and cancer therapy and chronic illness therapy scores will be measured. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and Proctor conceptual frameworks will be followed for evaluation of implementation. The main outcome measures are the mean total dose of UBSAs prescribed in 7 days and serious adverse events at 30 days. Data analysis will incorporate intention-to-treat, per-protocol and as-treated analyses for service outcomes (effectiveness, safety, quality of life assessments and cost-effectiveness) and mixed methods for implementation outcomes, informed by the Theoretical Domains Framework. We expect that the study results will inform health policy with improvement in hospital services in treating stable sNF, evidenced by improved safe antibiotic stewardship, early antibiotic de-escalation and reduced costs and length of stay.

Ethics and dissemination

The institutional review boards of all study sites approved this study. This study will establish the ASTERIC protocol safely improves antibiotic stewardship and clinical management in adult patients with sNF. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities. All patients with sNF will be influenced by the new protocol which is agreed at hospital level. Randomisation is at hospital level, not patient level. Patient consent is sought for follow-up and data access, not for treatment. Staff consent is sought for interviewing.

Trial registration number

NCT06794320.

Incidence and predictors of delirium in patients admitted to intensive care unit at comprehensive specialised hospitals in Amhara region, northwest Ethiopia: a multicentre prospective observational study

Por: Asmare · T. B. · Wubet · H. B. · Gobezie · N. Z. · Deress · G. M. · Belete · K. G. · Tadesse · M. A. · Abuhay · A. G. · Demissie · B. · Melesew · A. A. · Afework · W. A. · Alle · Y. F. · Demite · D. G. · Teshome · D. · Mossie · K. D. · Kassa · B. D. · Gedefaw · G. D.
Objective

To assess the incidence of delirium and its predictors among adult patients admitted to the intensive care units of comprehensive specialised hospitals in the Amhara region of northwest Ethiopia from 18 October 2024 to 20 February 2025.

Design

A multicentre prospective observational study was conducted.

Setting

Four comprehensive specialised hospitals in the Amhara region of northwest Ethiopia, from 18 October 2024 to 20 February 2025.

Participants

A total of 351 patients were included in the final analysis during the study period.

Outcome measures

The primary outcome measure of this study was the incidence of delirium. Additionally, the study investigated the factors associated with delirium incidence among adult patients admitted to intensive care units.

Results

The incidence of delirium among adult patients in intensive care units was 42.17% (95% CI: 37.08 to 47.42). Pain (adjusted HR (AHR) = 4.74; 95% CI: 2.38 to 9.44), mechanical ventilation (AHR = 2.96; 95% CI: 1.56 to 5.63), age 65 years or older (AHR = 2.18; 95% CI: 1.48 to 3.21) and agitation (Richmond Agitation-Sedation Scale (RASS) ≥1) (AHR = 3.26; 95% CI: 2.09 to 5.09) were statistically significant factors associated with delirium.

Conclusion and recommendation

In the present study, more than one-third of patients developed delirium. Pain, mechanical ventilation, age 65 or older and agitation (RASS≥1) were significantly associated with delirium occurrence. To reduce the incidence of delirium, the current study recommends treating or preventing pain and agitation. Additionally, special attention should be given to patients receiving mechanical ventilation and those aged 65 or older during care.

Patient-cost studies on self-administered treatment (SAT) for drug-sensitive tuberculosis compared to facility-based directly observed treatment, short-course (DOTS): a protocol for a systematic review

Por: Ndlangalavu · Y. F. · Christian · C. S.
Introduction

Many patients with tuberculosis (TB) suffer from a huge economic burden, even though TB services are often provided free of charge at the point of care. Costs can create significant barriers, hindering patients’ access to TB treatment. These costs include direct medical costs (such as consultation fees), direct non-medical costs (such as transportation costs) and indirect costs (such as wages foregone). This systematic review aims to synthesise the best available evidence on economic evaluations of patient-cost studies on self-administered treatment (SAT) for drug-sensitive TB compared with facility-based directly observed treatment, short-course (FB DOTS), globally.

Methods and analysis

We will conduct a systematic review following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines and search PubMed, Academic Search Complete, Scopus, CINAHL Plus (EBSCO) and Google Scholar for articles published up to 2025, without date restrictions. Eligible studies must be full or partial (cost analyses without effectiveness data) economic evaluations conducted globally, comparing SAT to FB DOTS regarding TB patient costs. Grey literature will be included. Exclusion criteria include studies not reporting patient costs between SAT and FB DOTS, and non-economic evaluations (non-original research). Two independent reviewers will conduct the screening, data extraction and quality assessment. A quality assessment will be performed using the Consolidated Health Economic Evaluation Reporting Standards statement, the Consensus on Health Economic Criteria checklist and the ROBINS-I tool.

Ethics and dissemination

Ethics approval is not required for this systematic review because it does not use individual patient data. Instead, we will use publicly available economic evaluation research studies. Findings will be presented at international and national conferences and published in open-access, peer-reviewed journals.

PROSPERO registration number

CRD42024591221.

Exploring prehospital emergency care challenges and interventions to reduce emergency department overcrowding: a qualitative meta-synthesis

Por: Chua · E. · Ji · S. · Kok · H. W. · Lai · Y. F. · Chua · C.
Background

Challenges within prehospital emergency care (PEC) have significant implications for the provision of emergency department (ED) care. However, ED overcrowding is a prevalent issue with negative impacts on patient outcomes. It can be attributed to multiple factors, such as non-emergency attendances, inaccessible alternative care service pathways (ACSPs) and inefficiencies in emergency medical service operations. ED overcrowding has prompted healthcare systems worldwide to implement interventions. These include tele-triaging, virtual ED and non-conveyance protocols that primarily aim to reduce demand for ED care and increase the supply of alternative services. However, despite such efforts, there remain unaddressed limitations that prevent PEC interventions from being successfully implemented. Moreover, prior studies and reviews have found mixed results, and that ED overcrowding interventions remain underused. Therefore, there is a need for this qualitative systematic review and meta-synthesis to capture the complexities of implementation challenges and identify enablers required to complement PEC interventions.

Objectives

This systematic review and meta-synthesis aims to offer a consolidated overview of PEC interventions intended to reduce ED overcrowding. It focuses on presenting international perspectives on the current challenges these interventions face. The enablers presented in this review could also better inform the actions taken by healthcare systems aiming to implement similar interventions.

Methods

A comprehensive search of PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature Complete, PsycINFO, Web of Science and Scopus was conducted to obtain a set of qualitative studies. Following a quality appraisal with the Critical Appraisal Skills Programme tool, data from the included studies were extracted and meta-synthesised.

Results

A final 21 qualitative intervention-based studies were included. Through these studies, four themes were identified: (1) types of PEC interventions to alleviate ED demands and right-site patients, (2) perceived benefits of interventions, (3) challenges in implementing interventions and (4) key enablers for successful implementation of interventions. Our results describe key factors such as the importance of ACSPs and support for PEC healthcare workers in the form of standardised guidelines, as well as education and training.

Conclusion

We further discuss how enablers can integrate into current PEC systems to complement the interventions explored. Discussions are concentrated on several key interventions (tele-triaging, virtual ED and non-conveyance protocols) as they were perceived to hold significant potential in addressing PEC challenges and could be further elevated through various enablers. Overall, we could conclude that each intervention needs to be complemented by enablers to optimise its benefits.

Coproducing a new scale with young people aged 10-24 years: a protocol for the development and validation of the Youth Loneliness Scale (YLS)

Por: Fuhrmann · D. · Riddleston · L. · Verity · L. · Alam · I. · Chavez · L. · Conway · J. · Niaz · A. · Pollmann · A. · Qualter · P. · Spowage · P. · Turner · L. · Walibhai · W. · Lau · J. Y. F.
Introduction

The high prevalence of loneliness in young people, aged 10–24 years, is increasingly recognised as an urgent global health concern. The experience of loneliness is linked to a wide range of adverse physical and mental health outcomes. A lack of loneliness scales that can accurately capture the authentic experiences of young people has hampered progress in our understanding of the aetiology and sequelae of youth loneliness, as well as the development of preventative policies and interventions. Here, we provide a protocol for developing and validating an age-sensitive loneliness scale for young people aged 10–24 years: the Youth Loneliness Scale (YLS). The scale is designed to measure loneliness in the general population of young people in the UK.

Methods and analysis

The scale is coproduced with young people from design to dissemination. The scale development process follows a three-phased, multistep approach that includes item development, scale construction and scale evaluation. Item development is achieved via deductive (literature review) and inductive methods (arts workshops and focus groups), as well as a Delphi survey of experts (by profession and experience) for initial refinement. The scale is then constructed via pretesting items in cognitive interviews with young people, and exploratory testing for preliminary evaluation and refinement. Finally, the scale is administered in confirmatory testing, where a full psychometric evaluation is provided.

Ethics and dissemination

The project was approved by the Queen Mary University of London Research Ethics Committee (Reference: 2024-0231-341) as the lead site and subsequently endorsed by the University of Manchester Research Ethics Committee. The YLS scale and results of its psychometric evaluation will be published open-access. The protocol provided here will allow researchers to evaluate the final scale generated against the plans set out. We also encourage the use and adaptation of the protocol to develop age-sensitive loneliness scales for other populations.

Physical exercise barriers and needs in adults with congenital heart disease: a qualitative study

Por: Langeveld · Y. F. · ter Hoeve · N. · van den Bosch · A. · Robbers-Visser · D. · Kauling · R. M. · van Groen · J. C. · Sunamura · M. · Jorstad · H. T. · Snaterse · M.
Objective

Regular physical exercise has well-known health benefits and is generally considered safe for adults with congenital heart disease (ACHD). However, many individuals with ACHD remain insufficiently physically active. This study explored the barriers and needs related to physical exercise as experienced by people with ACHD to inform the development of tailored strategies that support and promote increased physical activity.

Methods

Qualitative study using semistructured interviews conducted between March and May 2023. The interview guide was based on the Fear Avoidance Model, Tampa Scale for Kinesiophobia Heart and European Society of Cardiology guidelines on sports cardiology and exercise for cardiovascular diseases. Interviews were coded and thematically analysed to identify specific physical exercise barriers and needs.

Results

Data saturation was reached after interviewing 19 individuals living with ACHD (median age 46 years (range 24–75), 10 women). Thematic analysis identified four main barriers: (1) physical symptoms and negative past experiences, (2) alienation from peers, (3) perceived decline in physical fitness over time and (4) lack of knowledge about personal physical boundaries. Two needs were identified: (1) personalised, disease-specific exercise information and advice and (2) structured support and guidance from healthcare professionals.

Conclusions

People with ACHD face multiple barriers to engaging in physical exercise. There is a clear need for specific, personalised exercise advice from healthcare providers and the development of long-term programmes and interventions to overcome relevant barriers.

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