FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
Ayer — Diciembre 16th 2025Tus fuentes RSS

Investigating risk factors of hemorrhagic fever of renal syndrome (HFRS) in Qingdao, Shandong province, China

by Ying Li, Jing Jia, Runze Lu, Liyan Dong, Lizhu Fang, Litao Sun, Zongyi Zhang, Qing Duan, Lijie Zhang, Kunzheng Lv, Huilai Ma

Background

Qingdao, a historically high-risk area for hemorrhagic fever with renal syndrome (HFRS) in China, is undergoing agricultural mechanization and urbanization. However, the specific risk factors for HFRS in this context remain unclear. This study sought to determine the risk factors for HFRS in Qingdao.

Methods

Community-based, 1:2 case-control study. Each case was matched with two healthy neighborhood controls based on biological sex, age, and the same neighborhood or village. Univariate and multivariate conditional logistic regression analyses were performed. Furthermore, stratified analyses were performed to explore risk factor heterogeneity between the peak season for Hantaan virus (HTNV) type HFRS (October-January) and other months.

Results

93 cases (73.2%, 93/127) reported from January 2022 to September 2023 and 186 controls completed this questionnaire. Farmers accounted for the highest proportion (68.8%, 64/93). In multivariate logistic regression analysis, there were three significant risk factors for HFRS: piles of firewood and/or grain in residential yards (odds ratio [OR]=3.75, 95% CI: 2.14–6.55), mite and/or flea bites (OR=1.83, 95% CI: 1.06–3.18) and contacting with rats and/or their excreta (OR=1.73, 95% CI: 1.09–2.74); three variables represented significant protective factors for HFRS: frequency of sun exposure for quilts and bedding (OR=0.41, 95% CI: 0.19–0.90), rodent control measures at home (OR=0.50, 95% CI: 0.30–0.81) and knowing the main sources of HFRS transmission (OR=0.58, 95% CI: 0.36–0.90). Stratified analysis revealed that the influence of these factors varied by season, with rodent contact and control measures being particularly salient during the HTNV peak season.

Conclusion

This study provides the first comprehensive evidence of risk and protective factors for HFRS in Qingdao, highlighting the role of rodent control, promoting comprehensive health education, environmental management, and personal protection. However, the results should be interpreted considering the study’s limitations, including a 73.2% response rate and the potential for recall bias.

Optimising time-limited trials in acute respiratory failure: a multicentre focused ethnography protocol

Por: Kruser · J. M. · Wiegmann · D. A. · Nadig · N. R. · Secunda · K. E. · Hanlon · B. M. · Moy · J. X. · Ahmad · A. · Campbell · E. G. · Donnelly · H. K. · Martinez · F. J. · Polley · M. · Orhan · C. · Korth · E. · Stalter · L. N. · Rowe · T. J. · Wu · A. L. · Viglianti · E. M. · Eisinger · E
Introduction

The ‘time-limited trial’ for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient’s response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.

Methods and analysis

We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials’ conceptual formulation and their heterogeneous, real-world use.

Ethics and dissemination

This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.

Trial registration number

NCT06042621.

AnteayerTus fuentes RSS

Is there a role for anticoagulation with dabigatran in S. aureus bacteremia? Protocol for the adjunctive treatment domain of the Staphylococcus aureus Network Adaptive Platform (SNAP) randomised controlled trial

Por: McDonald · E. G. · Cheng · M. P. · Davis · J. S. · Goodman · A. L. · Lawler · P. R. · Marsh · J. · Mertz · D. · Paul · M. · Rodriguez-Bano · J. · Siegal · D. M. · Tong · S. Y. · Walls · G. · Lee · T. C. · The SNAP Global Trial Steering Committee · Bonten · Daneman · van Hal · Heriot
Introduction

Many patients receive oral anticoagulation for reduced stroke risk in atrial fibrillation or as treatment or prevention of venous thromboembolism. Oral factor Xa inhibitors (oral FXaI, eg, apixaban, edoxaban or rivaroxaban) are commonly prescribed for this indication. Dabigatran, an oral direct thrombin inhibitor, is similarly approved. In vitro and animal model evidence suggests that dabigatran also has direct effects on Staphylococcus aureus virulence and infection. Observational data have shown that dabigatran users are less likely to develop S. aureus bacteremia (SAB), and a small randomised controlled trial showed that dabigatran has anti-S. aureus effects when compared with low molecular weight heparins during bloodstream infection. We seek to answer whether dabigatran is superior to the oral FXaIs in achieving better SAB outcomes among patients who independently require oral anticoagulation. We report the intervention-specific protocol, embedded in an adaptive platform trial.

Methods and analysis

The S. aureus Network Adaptive Platform (SNAP) trial [NCT05137119] is a pragmatic, randomised, multicentre adaptive platform trial that compares different SAB therapies for 90-day mortality rates. For this intervention (‘Dabi-SNAP’), patients receiving therapy with an oral FXaI will be randomised to continue as usual or to change to dabigatran as of the next scheduled dose. All subjects will receive standard of care antibiotics and/or antibiotics allocated through other active domains in the platform. As the choice of anticoagulant may not demonstrate large differences in mortality, a ranked composite of death and adverse outcomes (Desirability of Outcome Ranking, or DOOR) was chosen as the primary outcome.

Ethics and dissemination

The study is conditionally approved by the research ethics board of the McGill University Health Centre: identifier 2025-10900. Trial results will be published open access in a peer-reviewed journal and presented at a global infectious disease conference. The trial is registered at clinicaltrials.gov with the identifier NCT06650501.

Trial registration number

NCT0665050.

DIVINE-pilot trial: a phase 2 multicentre, randomised pilot trial of pharmacotherapy and physical activity monitoring conducted in women with recent gestational diabetes and increased risk of type 2 diabetes recruited from tertiary referral hospitals in A

Por: Chen · A. X.-N. · Lee · V. Y. · Donges · K. · Giancas · C. · Angell · B. · Parmenter · B. · Barrett · H. L. · Henry · A. · Patel · A. · Arnott · C.
Introduction

Women who develop gestational diabetes mellitus (GDM) have a 60% lifetime risk of developing type 2 diabetes mellitus (T2D), which is already elevated within the first decade following childbirth. Despite the impact of lifestyle interventions to reduce long-term T2D risk in women with previous GDM, successful implementation of lifestyle interventions remains a barrier. Metformin is recommended for adults at increased risk of developing T2D; however, there is limited evidence of tolerability in the early postpartum period. Glucagon-like peptide 1 receptor agonists (GLP-1 RA) are effective at improving glycaemic status and body weight. However, GLP-1 RA have not been evaluated in the postpartum population. Finally, physical activity monitors may support behaviour changes related to physical activity to reduce long-term risk of T2D but are yet to be studied following GDM.

Methods and analysis

This will be a multicentre, randomised, open-label interventional pilot study. Using a 2x2 factorial design, we will examine the feasibility and acceptability of a pharmacotherapy intervention and a physical activity intervention in women with previous GDM at increased risk of developing T2D. Participants will be recruited from tertiary referral hospitals in Australia and will be randomised to receive either metformin alone or in combination with a GLP-1 RA and subsequently randomised to either a physical activity intervention involving activity monitor use, or usual care for 6 months, followed by a 6-month follow-up period. Primary feasibility outcomes include the acceptability and safety of the metformin and GLP-1 RA as measured through pill and injection counts, acceptability questionnaire and adverse events.

Ethics and dissemination

This trial is registered with the Australian and New Zealand Clinical Trials Registry (Registration Number: ACTRN12624001253594). This trial has received ethics approval from the South Eastern Sydney Local Health District Human Research Ethics Committee (Approval Number: 2024/ETH00042, protocol version v1.1, 28/02/2025).

Trial registration number

Australian and New Zealand Clinical Trials Registry, Registration Number: ACTRN12624001253594.

Drug-related stigma among people who inject drugs – development and validation of the drug use stigma scale (DUSS)

by Robin A. Pollini, Catherine E. Paquette, Brandon Irvin, Jennifer L. Syvertsen, Christa L. Lilly

Drug use is a highly stigmatized behavior, and drug-related stigma is a key driver of behavioral risk, lower health care utilization, and associated adverse health outcomes among people who inject drugs (PWID). While instruments exist for measuring drug-related stigma, their applicability to community-based PWID across multiple stigma types (enacted, anticipated, internalized) and settings (health care, society, family) is limited, as most were developed using treatment-based samples and all were developed in urban populations. This study sought to develop a Drug Use Stigma Scale (DUSS) that addresses these limitations. We developed an initial list of 39 items based on literature review and qualitative interviews (N = 27) and three focus groups (N = 28) with PWID recruited from syringe services programs and via peer referral in two predominantly rural West Virginia counties. The scale items were administered in a survey to 336 PWID recruited from the same two counties divided into development and validation samples. Responses to the 39-item scale went through a multidimensional refinement process, including examination of internal consistency, Confirmatory Factor Analysis (CFA), and a three-factor CFA based on stigma setting. Next, a set of final measurement CFAs were conducted. Finally, the resulting scale was examined for criterion-related concurrent validation. The final DUSS consisted of 16 items with excellent fit statistics for the development sample: SRMR: 0.03, RMSEA: 0.09, GFI: 0.92, CFI: 0.96, NFI: 0.94. Fit attenuated but remained satisfactory for the validation sample. DUSS scores were significantly associated with increased odds of not seeking healthcare when needed (OR: 1.47, p = 0.001; OR: 1.61, p 

Participants experiences with the Delphi method: an online evaluation of a three-round Delphi across German-speaking countries

Por: Niederberger · M. · Dieudonne · J. · Schifano · J. · Vogt · S.
Objectives

This study evaluates how participants experienced and assessed a three-round Delphi study on the terminology of developmental language disorders in childhood. It compares participants who completed all rounds (completers) with those who withdrew early (dropouts) and aims to derive methodological quality criteria for future Delphi studies.

Design

The evaluation is based on a Delphi study conducted in 2021/2022 across five German-speaking countries. After the final round, n=179 experts (40% response rate) completed a standardised survey assessing their expertise, motivation, reasons for discontinuation, time commitment and perceptions of questionnaire and feedback design. Responses from completers (n=156) and dropouts (n=23) were analysed descriptively.

Results

Most participants had no prior experience with Delphi methods but rated the study positively and considered the topic highly relevant. Completers reported their subjective time commitment to be lower and rated the handling of the questionnaire more positively than dropouts. Feedback was used by nearly half of all experts and was more actively considered by completers. Lack of time was the most common reason for discontinuation.

Conclusion

The findings confirm the feasibility and acceptance of the Delphi method in interdisciplinary health research. In addition to established methodological principles, topic relevance, clear communication and time commitment emerged as key areas for expert motivation and engagement.

Study protocol for a multi-site case study evaluation of a Canadian quality improvement collaborative to improve Baby-Friendly practices in community health services

Por: Turner · S. E. · Enns · J. E. · Seager · E. · LeDrew · M. · Benoit · B. · Semenic · S. · Snelgrove-Clarke · E. · Shittu · B. · Gordon Pappas · D. · CBFI-C Implementation and Evaluation Team · Nickel · N. C. · Campbell-Yeo · Frittenburg · Haiek · McClure · Rashid · Swan · Abbass-Di
Introduction

In Canada, many families want to breastfeed, but there are several common challenges they may encounter. Currently, 91% of Canadian families initiate breastfeeding after giving birth, yet only 38% of babies are breastfed exclusively to 6 months. In 1991, the Breastfeeding Committee for Canada (BCC) was established to implement the World Health Organization’s Ten-Step Baby-Friendly Hospital Initiative, a series of evidence-based in-hospital practices to support families to breastfeed. Then, in recognition of the need to support breastfeeding beyond the hospital setting, the BCC expanded the Baby-Friendly Initiative (BFI) to apply the Ten Steps to both hospitals and community health settings. However, uptake of the BFI Ten Steps in community settings has been low and methodology on how to optimise implementation of the Ten Steps in community is not well developed. Therefore, the objective of this project is to develop and evaluate a quality improvement collaborative with 25 community health services from across Canada to learn how to best support the implementation of the BFI Ten Steps in community, with the ultimate goal of improving breastfeeding outcomes.

Methods and analysis

This protocol describes the activities of the Community Baby-Friendly Initiative Collaborative (CBFI-C) and the methods used to evaluate its effectiveness. We will use the Institute for Healthcare Information Breakthrough Series (IHI-BTS) model, a proven quality improvement model that has been widely used in clinical settings, but is not yet widely used in community settings. The IHI-BTS combines three virtual learning sessions with action cycles that allow the participating sites time to test and track small practice changes. Sites will be asked to track care indicator and breastfeeding outcome data, engage in monthly webinars, receive coaching from trained mentors, participate in focus groups and participate in a final summative workshop. We will use a multi-site case study approach, combining aggregate care indicator data and qualitative data from webinars, focus groups and workshops to evaluate how the CBFI-C model supports community sites in the process of implementing the BFI Ten Steps.

Ethics and dissemination

Ethics approval for this evaluation was obtained from the CHIPER Health Research Ethics Board (Number HS26947-H2025:157)). The results of the CBFI-C evaluation will be shared in a report, peer-reviewed publications and presentations to government and academic audiences. The findings will inform effective quality improvement strategies to enhance uptake of the BFI in community health settings.

Assessing the feasibility of a platform trial for Gram negative bloodstream infections: results from the vanguard phase of BALANCE+

Por: Daneman · N. · Johnstone · J. · Lee · T. C. · MacFadden · D. R. · McDonald · E. G. · Morpeth · S. C. · Ong · S. W. X. · Paterson · D. L. · Pinto · R. L. · Rishu · A. · Rogers · B. A. · Yahav · D. · Coburn · B. · Daley · P. · Das · P. · Fiest · K. · Findlater · A. · Fralick · M. · George · M
Objectives

Gram negative bloodstream infections (GN BSI) are a leading cause of mortality worldwide, and antibiotic treatment approaches remain understudied. BALANCE+ is a perpetual Bayesian adaptive platform trial to test multiple treatment questions for hospitalised patients with GN BSI. The vanguard phase objective was to test the feasibility of the main trial.

Design

Adaptive platform trial with five initial domains of investigation, each with open label 1:1 randomisation.

Setting

Ten hospitals across four Canadian provinces.

Participants

Individuals admitted to hospital with blood cultures yielding Gram negative bacteria.

Interventions

The five initial domains of investigation included: antibiotic de-escalation versus no de-escalation; oral transition to beta-lactam versus non-beta-lactam treatment; routine versus no routine follow-up blood cultures (FUBCs); central vascular catheter replacement versus retention; and, ceftriaxone versus carbapenem treatment for low risk AmpC organisms.

Primary outcome measures

Domain-specific recruitment rates and protocol adherence.

Results

During the vanguard phase, 719 patients were screened, of whom 563 (78.3%) were eligible, with 179 (31.8%) enrolled into the platform. The platform recruitment rate was 1.37 patients/site-week. Recruitment varied by domain: routine versus no FUBC domain 1.23 patients/site-week; oral beta-lactam versus non-beta-lactam domain 0.48; de-escalation versus no de-escalation domain 0.28; low risk AmpC domain 0.02; catheter replacement versus retention domain 0.01. Domain specific protocol adherence rates were 145/158 (91.8%) for routine versus no routine FUBC, 53/60 (88.3%) for oral beta-lactam versus non-beta-lactam, 26/33 (78.8%) for de-escalation versus no de-escalation, 3/3 (100%) for low risk AmpC, and 0/1 (0%) for line replacement versus retention. There was complete ascertainment of all study outcomes in hospital 170/170 (100%) and near complete ascertainment at 90 days 162/170 (95.3%).

Conclusions

The vanguard phase demonstrated overall trial feasibility by recruitment rate and protocol adherence, with differences across interventions, leading to a transition to the main BALANCE+ platform trial with minimal protocol modifications.

Trial registration number

NCT05893147.

HERNIIA-II trial (Hernia Endoscopic oR opeN repair In chIldren Analysis): a protocol of a multicentre randomised controlled trial to study the (cost-)effectiveness of laparoscopic hernia repair compared to open hernia repair in children 0-16 years

Por: Maat · S. C. · de Vreeze · L. E. · Eurlings · R. · Anema · J. · Van Baren · R. · Been · J. V. · van den Broek · F. · Cakir · H. · van Dongen · J. M. · Ferenschild · F. · de Graaf · J. · Nijveldt · R. · Ottenhof · A. · Ploeg · A. J. · Rippen · H. · Ruiterkamp · J. · Twisk · J. W. R. · Ver
Introduction

Inguinal hernia repair is one of the most frequently performed operations in the paediatric population and can be performed according to two approaches: open or laparoscopic. At present, decisive evidence about the best treatment strategy is lacking and consequently, there is an ongoing debate about the most (cost-)effective treatment for the paediatric inguinal hernia. The aim of the Hernia Endoscopic oR opeN repair In chIldren Analysis—trial (HERNIIA2-trial) is to estimate the (cost-)effectiveness of the laparoscopic percutaneous internal ring suturing (PIRS) technique compared with open repair in children aged 0–16 years with a primary unilateral inguinal hernia.

Methods and analysis

A national multicentre randomised controlled trial will be performed including 464 children aged 0–16 years with a primary unilateral inguinal hernia. Patients will be randomised between the open or PIRS technique. The primary outcome is the number of reoperations within 2 years after primary surgery. Secondary outcome measures are: operative and postoperative complications, total duration of surgery, postoperative pain, length of admission, time to normal daily activities, cosmetic appearance of the scar, social and healthcare costs and health-related quality of life. Furthermore, cost-effectiveness will be assessed from a societal and healthcare perspective.

Ethics and dissemination

The protocol was approved by the ethics committee of the Amsterdam University Medical Hospital. Informed consent will be obtained by parents and, if possible, according to age, by patient. The study will be conducted according to the principles of the Declaration of Helsinki (2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and Good Clinical Practice. Study findings will be disseminated through scientific publications, conferences and patient-friendly materials. The national study network of participating centres will facilitate rapid dissemination and implementation within the Netherlands and potentially abroad.

Trial registration number

ClinicalTrials.gov PRS (ID NCT06451432).

Fertility, family planning, pregnancy and motherhood among women doctors working in the EU and UK: a scoping review

Por: Biju · S. · Madden · C. · OConnor · P. · Byrne · D. · Humphries · N. · Jeffrey · G. · Finnegan · J. · ODonoghue · K. · Fitzgibbon · S. · Lydon · S.
Objectives

Women doctors face considerable challenges navigating family planning, pregnancy and motherhood. Their experiences can have relevance for health system functioning, including doctor retention. This scoping review synthesises research on family planning, fertility, pregnancy and motherhood among women doctors in the EU and the UK.

Design

Scoping review conducted according to JBI best practice guidance.

Data sources

MEDLINE, CINAHL, Academic Search Complete, PsycInfo and Web of Science were searched, and supplemented with backwards and forwards citation chasing.

Eligibility criteria

Peer-reviewed, original research, in English, focusing on either fertility and family planning, pregnancy and/or motherhood among women doctors in an EU country(s) and/or the UK.

Data extraction and synthesis

Data were extracted independently by two authors. Data were synthesised using deductive content analysis and collated using narrative synthesis.

Results

In total, 34 studies were identified. Family planning appears complicated by medical careers. Medical specialty choice is particularly impacted, with certain specialties (eg, General Practice) considered particularly family friendly and others markedly less so. Pregnancy complications among women doctors, especially surgeons, were documented. However, women doctors’ and non-doctors’ pregnancy outcomes were overall not significantly different. Notably, doctor-mothers had fewer children and were more likely to report making compromises or facing negative consequences when balancing family and career than doctor-fathers.

Conclusions

Women doctors in the EU and UK report challenges in balancing work and motherhood. With the potential for their experiences to impact on health system functioning and patient outcomes, training bodies and health organisations should take proactive action to better support women doctors and ensure they can remain in the profession and practice in their desired specialty. Future research examining working practices/schedules during pregnancy, breastfeeding experiences, parenting and childcare and maternal mental health will support a better understanding of women doctors’ experiences and facilitate implementation of effective supports.

Canadian cross-sectional survey of healthcare, social and community service providers capacity to respond to sex trafficked persons

Por: Forte · T. · Kosa · S. D. · Macdonald · S. · Mason · R. · Du Mont · J.
Objective

To examine the impact of the extent of education and/or training on sex trafficking among healthcare, social and community service providers and the impact of education and/or training on their capacity to respond to sex trafficked persons.

Design

Cross-sectional survey.

Setting

An anonymous, online survey assessing perceptions of, and capacity to respond to, sex trafficking was distributed between February and August 2023 via social media platforms and with professional healthcare, social service and community associations and organisations across Canada to share with their members.

Participants

553 healthcare, social and community service providers.

Outcome measures

Seven 6-point Likert scale items were used, as part of a larger survey, to measure capacity to respond to sex trafficking. Specifically, respondents were asked to rate their awareness of red flags and capacity to identify, talk to, interview, enhance the safety of, provide appropriate resources or referrals for and collaborate with other professionals to support sex trafficked persons.

Results

Although most respondents (86.8%) reported having received some education and/or training on sex trafficking, the vast majority (94.8%) believed that they would benefit from additional education and/or training. Compared with those with no previous sex trafficking education and/or training, those who received less than 5 hours of education and/or training (b=3.56, p

Conclusions

As the number of hours of education and/or training on sex trafficking increased, so did respondents’ capacity to respond to sex trafficked persons. These results highlight a need for more education and training to help build capacity among healthcare, social and community service providers in identifying sex trafficked persons and providing appropriate care. Appropriately trained service providers can better support sex trafficked persons’ complex needs and potentially mitigate adverse outcomes.

Effects of physical therapy on motor ability in patients with spinal muscular atrophy III: a study protocol for a randomised controlled trial

Por: Zhang · J. · Wang · B. · He · J. · Zhu · L. · Dong · X.
Introduction

Research investigating the efficacy of spinal muscular atrophy type II rehabilitation has yielded conflicting conclusions, underscoring the need for high-quality research to validate the role of physical therapy. Furthermore, exercise training should be considered as a potential non-pharmacological strategy to enhance motor function in SMA type III patients. Hence, this study is designed to explore the effectiveness of physical therapy for improving motor function in individuals with SMA type III.

Methods and analysis

This study is an open-label, randomised controlled trial. We will first stratify patients by disease severity (mild=independent walking, severe=non-ambulatory) and then randomly assign 428 participants to either the treatment group or the control group for a period of 12 weeks using a computer-generated randomisation schedule with a 1:1 allocation ratio. The intervention group will undergo a combination of cycling, resistance training, balance exercises, postural control training and locomotion exercises, while the control group will receive education sessions and a standard home exercise programme consisting of stretching and relaxation exercises. Outcome measurements will be assessed at baseline, immediately postintervention and at 3-month and 6-month follow-up assessments. The primary outcome will be assessed using the Hammersmith Functional Motor Scale Expanded, while secondary outcomes will include: Manual Muscle Test, Six-Minute Walk Test, 10 Metre Walk/Run Test, adverse events monitoring, Paediatric Quality of Life Inventory Multidimensional Fatigue Score and active and passive range of motion measurements.

Ethics and dissemination

The study protocol and consent form have been approved by the Ethics Committee on Biomedical Research of West China Hospital of Sichuan University (#2025-56) on 19 February 2025. Results will be published in peer-reviewed journals, presented at national and/or international conferences and disseminated to Chinese rare disease support groups.

Trial registration number

ChiCTR2500101177.

The cost-effectiveness of penicillin allergy assessment pathway (PAAP): a decision analysis

Por: Yang · M. · Bestwick · R. · Howdon · D. · Ahmed · S. · Powell · N. · Armitage · K. F. · Fielding · J. · Porter · C. E. · Savic · S. · West · R. M. · Howard · P. · Galal · U. · Pavitt · S. · Sandoe · J. A. · Mujica-Mota · R. E.
Objective

To evaluate the cost-effectiveness of implementing a penicillin allergy assessment pathway (PAAP) versus usual care within the NHS.

Design

A decision tree analysis over a 5-year time-period, informed by a randomised controlled trial (RCT) of PAAP and systematic review. Value of information analysis was also conducted to estimate the value of conducting a new trial.

Data sources

Model inputs were informed by the ALABAMA RCT participants included in the primary analysis, 811 adults with penicillin allergy labels and recent antibiotic prescriptions, and data from published literature.

Interventions

Participants in the ALABAMA trial included in the primary analysis: PAAP (n=401) and usual care (n=410).

Primary and secondary outcome measures

Costs are presented in GBP (£) at 2022–2023 prices, quality-adjusted life years (QALYs), incremental cost-effectiveness ratio, incremental net monetary benefit (INMB), the probability of cost-effectiveness at the £20,000 and £30,000 per QALY threshold, and the cost effectiveness of a new follow-on trial.

Results

PAAP had incremental costs of £–83 (probability of cost saving 47.5%) and incremental QALYs of 0.036 (probability of positive benefits 47.5%). The INMBs (probability of cost-effectiveness) were £806 (48%) and £1167 (48%) under the decision thresholds of £20,000 and £30,000 per QALY, respectively. PAAP was more cost-effective among females, people aged >65 years, and more frequent antibiotic users. A new follow-on trial involving 1267 participants was estimated to cost £2.4 million and, by reducing uncertainty in the evidence, would avoid £19.6 million in costs of incorrect management decisions for eligible patients over the next 10 years.

Conclusion

The PAAP was considered cost-effective, but significant uncertainty remained. Future trials with adequate power and longer follow-up are needed to determine the most cost-effective models for penicillin allergy testing.

Trial registration number

ISRCTN20579216.

Trends in incident acute rheumatic fever or rheumatic heart disease in Indigenous youth in Western Australia: a retrospective cohort study

Por: MacDonald · B. · Sodhi-Berry · N. · Stacey · I. · Robinson · M. · Carapetis · J. · Bowen · A. C. · Budgeon · C. · Nedkoff · L. · Katzenellenbogen · J. M.
Objective

To determine age-specific and age-standardised incidence trends of acute rheumatic fever (ARF) or rheumatic heart disease (RHD) among Indigenous Western Australians aged less than 35 years of age.

Design

A population-based retrospective cohort study with linked data analysis.

Setting

Western Australian hospital admissions (1996–2022) and RHD notifications to the state-based register (2011–2015).

Participants

Patients, both Indigenous and non-Indigenous aged

Results

Of 1746 incident ARF/RHD cases, 1526 (87%) were Indigenous peoples, with the highest rates observed in patients aged 5–14 years, with an annual estimated increase of 4.3% (95% CI 3.2% to 5.2%). The 0–4 years age group experienced an annual increase in incidence rates of 4.8% (95% CI 1.4% to 8.2%). Overall, Indigenous patients experienced an annual increase of 1.9% (95% CI 1.3% to 2.6%) from 1996 to 2022. However, most cases (n=894) were identified after multiple significant policy developments (2011–2022) with an annual increase of 5.7% (95% CI 3.7% to 7.5%) for this period.

Conclusion

Increasing trends of incident ARF/RHD were observed in Indigenous patients aged under 15 years, with the greatest annual increments observed after policy implementation for disease reporting and awareness in the period from 2011 to 2022. Improvement in case ascertainment of ARF/RHD may be contributing towards increasing trends with improved reporting and monitoring of incident cases in very young Indigenous Australians more recently.

Study protocol for a randomised controlled trial to determine the efficacy of lisdexamfetamine for the treatment of acute methamphetamine withdrawal in inpatient settings

Por: Acheson · L. S. · Siefried · K. J. · Lintzeris · N. · Dunlop · A. J. · Haber · P. S. · Arunogiri · S. · Christmass · M. · Doyle · M. · Donoghoe · M. · Nagle · J. · Clifford · B. · McKetin · R. · Lubman · D. I. · Brett · J. · Taylor · N. · Carr · A. · Levin · F. R. · Shoptaw · S. · Ezard · N
Introduction

Harms due to methamphetamine use disorder (MAUD) are rising globally. Untreated withdrawal symptoms perpetuate the cycle of dependence and are a barrier to treatment. There is no pharmacotherapy approved for methamphetamine withdrawal. Lisdexamfetamine (LDX) dimesylate has potential as an agonist therapy to ameliorate symptom severity during acute methamphetamine withdrawal and increase duration of initial abstinence and retention in treatment.

Methods and analysis

We will conduct a double-blind, randomised, controlled trial to evaluate the efficacy of LDX in reducing symptom severity during acute methamphetamine (MA) withdrawal. One hundred eighty-four adults with moderate to severe MAUD presenting to a health service requesting MA withdrawal treatment who report use of MA within the last 72 hours will be recruited. Participants will be randomised 1:1 to receive a tapering dose of lisdexamfetamine (250 mg on day 1, reducing by 50 mg per day to 50 mg on day 5, followed by 2 days of placebo washout on days 6 and 7), or placebo for 7 days. The study will be conducted over 7 days in an inpatient unit, and all participants will also receive standard inpatient withdrawal care. Participants will be followed up in the community to day 84. The primary outcome is efficacy, defined as the between-group difference in average withdrawal severity measured over the 7-day admission by the Amphetamine Withdrawal Questionnaire. Secondary outcomes are retention in treatment, treatment satisfaction, sleep and concomitant medication use (symptomatic medications and medications for other indications to day 7); safety, craving for MA, post-treatment withdrawal symptoms, depression, anxiety and stress, insomnia and cost effectiveness (to day 28) and MA use, mental, physical and social health and post-withdrawal treatment utilisation (to day 84). A First Nations qualitative substudy will assess the experiences of Aboriginal and Torres Strait Islander participants, ensuring the treatment meets the needs of First Nations people.

Ethics and dissemination

This protocol was first approved by the St Vincent’s Hospital Human Research Ethics Committee on 15/05/2024 (2024/ETH00788). All participants will be provided with a participant information sheet and consent form, be fully informed about the study and given ample time to consider participation. Results will be published in peer-reviewed journals and presented at national and international conferences. Findings will be presented such that individual participants will not be identifiable.

Trial registration number

ACTRN12624001061527.

Acute stroke management in the Caribbean: a scoping review protocol

Por: Clervius · H. · Wroblewski · T. H. · Bennett · N. · Wells · M. J. · Lee · M. · Crandon · D. · Then · R. · Aidoo-Frimpong · G. · Etienne · M. · Dos Santos Rubio · E. J. · March-Downer · T. · Inoa · V. · Barthelemy · E. J. · Gordon Perue · G.
Introduction

Stroke is a leading cause of death and disability in the Caribbean, yet there is limited published information on the availability and utilisation of diagnostic imaging and treatment methods. Inequities in healthcare infrastructure, access to neuroimaging and acute treatment options may contribute to poorer outcomes following stroke, particularly in the low-resource settings that characterise most of the Caribbean region. The objective of this review is to map the literature on access to diagnostic and therapeutic modalities for adult stroke care in the Caribbean to identify potential limitations in acute treatment and examine how restricted access may impact outcomes. The resulting data can help inform strategies for improving access to stroke care in resource-limited communities.

Methods and analysis

We will apply a three-step strategy based on the Joanna Briggs Institute methodological framework: first, a limited search to identify relevant articles; second, selection of key search terms; third, implementation into a comprehensive search strategy. The query will range from 1 January 1995 to 1 June 2025 (date of final search). Search results will be extracted and screened by two independent reviewers, and findings will be presented in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. We will consider studies focusing on ischaemic and haemorrhagic stroke in the Caribbean, emphasising access to diagnostic imaging, stroke centres, prehospital management and emergent treatment. Studies examining acute stroke management capacity within the region will be considered. Studies will be excluded if they: focus exclusively on primary stroke prevention, postacute care, longitudinal care pathways for stroke victims or paediatric populations; are unrelated to stroke diagnosis or treatment or are conducted outside the Caribbean.

Ethics and dissemination

This protocol aims to perform secondary analysis of previously published literature; therefore, ethical approval is not required. The results of this review will be disseminated through academic conferences and peer-reviewed publication.

Combining transcriptomics with network pharmacology to explore the mechanism of Yiqi Huoxue decoction against liver fibrosis

by Yao-Yao Mao, Ke Zhang, Dan-Dan Zhao, Jia-Wei Cui, Zhan-Dong Lin, Cong-Yue Zhang, Yue-Min Nan

Background

Clinical practice commonly uses the Yi-qi Huo-xue formula (YQHX), a traditional Chinese herbal medicine comprising eight herbal components, to treat liver fibrosis resulting from various etiologies. Nevertheless, this formula’s specific active constituents and underlying mechanisms of action remain to be fully elucidated.

Methods

The drug components of YQHX and potential targets for liver fibrosis were identified via the screening of the various databases. Qualitative and quantitative identification of chemical components of drug-containing serum by Ultra Performance Liquid Chromatography (UPLC).Liver fibrosis was induced in mice through the intraperitoneal injection of carbon tetrachloride, followed by oral administration of YQHX. RNA-Seq quantified transcriptomic profiles in liver tissue.The degree of liver fibrosis was assessed via histopathology staining, the transcription and expression of relevant proteins were analyzed. Primary cells were isolated for in vitro experiments to validate the influence of YQHX on the associated signaling pathways.

Results

Network pharmacology identified IL-1β, IL-6, and TNF-α as potential targets for YQHX in treating liver fibrosis.The UPLC detected multiple potential active components. In vivo experiments showed that YQHX reduced serum AST and ALT levels in liver fibrosis-induced mice, decreased liverIL-1β, IL-6, and TNF-α levels, and improved liver fibrosis.The results of transcriptomics suggest that YQHX can reduce the expression of “collagen-activated signaling pathway,” “MyD88-dependent toll-like receptor signaling pathway,” “fibrinolysis” and “toll-like receptor 4 signaling pathway”. Furthermore, YQHX reduced the aggregation of M1 macrophages in the portal area and the deposition of α-SMA. Primary bone marrow-derived cells successfully transformed into M1 macrophages after induction, and YQHX reduced the levels of IL-1β, IL-6, and TNF-α in the supernatant of M1 macrophage culture and decreased the activation of primary hepatic stellate cells indirectly co-cultured with the supernatant. Interestingly, TLR4 agonists weakened this inhibitory effect. Both in vitro and in vivo experiments demonstrated that YQHX could inhibit the expression of the TLR4/TRAF6/MyD88 pathway in M1 macrophages.

Conclusion

We reveal here the molecular mechanism and signaling pathway of YQHX in treating liver fibrosis by utilizing network pharmacology in conjunction with in vivo and in vitro experiments. The findings offer insights that may advance the clinical application of YQHX.

Perceptions and attitudes of healthcare workers towards the use of digital facial recognition application in a health setting in Uganda: An exploratory pilot study

by Patrick Kaggwa, Juliet Nabbuye Sekandi, Mcdonald Kerone Adenike, Peter Nabende, Sarah Nabukeera, Kenneth Kidonge Katende, Esther Buregyeya, Nazarius Mbona Tumwesigye

Background

Unique patient identification is often challenging in healthcare systems, especially in low- and middle-income countries. Digital facial recognition is a promising alternative to traditional identification methods. This pilot study explores the perceptions and attitudes of healthcare workers towards using facial recognition technology in a healthcare setting in Uganda.

Methods

We conducted an explorative qualitative study using key informant interviews with healthcare workers in Kampala, Uganda, to assess perceptions and attitudes towards digital facial recognition. We interviewed a total of 10 healthcare workers, including five doctors and five nurses, aged 20–39 years, with at least one year of professional experience. A trained interviewer provided a brief overview and demonstration of the facial recognition application and then used an open-ended interview guide to elicit responses about perceptions and attitudes. The interviews were audio recorded and transcribed verbatim. Data obtained from Key Informant Interviews were manually analyzed using thematic content analysis.

Results

Overall, the healthcare workers perceived digital facial recognition as a more effective and acceptable way to identify patients who receive service at outpatient clinics. Four themes emerged, including: i) Challenges affecting current patient identification standards, ii) Healthcare workers’ views on facial recognition, iii) Perceived digital facial recognition implementation challenges, and iv) Solutions to challenges of digital facial recognition. The healthcare workers recommended ensuring the protection patients’ images privacy, providing adequate technological infrastructure in clinics, and securing stable internet access for the successful implementation of digital facial recognition.

Conclusion

Our exploratory study indicates that overall, healthcare workers have a positive perception of the digital facial recognition application. However, it is crucial to acknowledge and address concerns regarding confidentiality and privacy to pave the way for the future implementation of the system.

Identification of novel molecular drivers, prognostic and diagnostic biomarkers for Inflammatory Bowel Disease (IBD): protocol for the Nottingham/AstraZeneca prospective IBD observational cohort study

Por: Serna-Valverde · A. L. · Rodriguez-Suarez · E. · Marks · D. J. B. · Gehrmann · U. · Neisen · J. · Clarke · S. · Chew · T. S. · Cummings · F. · De Silva · S. · Gordon · J. N. · Knight · P. · Limdi · J. · Patel · K. · Crooks · B. · Sebastian · S. · Polytarchou · C. · Hannan · N. R. F. · Mo
Introduction

Crohn’s disease (CD) and ulcerative colitis (UC) are chronic, inflammatory bowel diseases (IBDs) of unknown origin, affecting the gastrointestinal tract and often causing extraintestinal symptoms. Conventional treatments (eg, glucocorticosteroids, immunomodulators) and targeted advanced treatments, including anti-TNFα, antibodies to p40 subunit of IL-12/23, antibodies to p19 subunit of IL-23, anti-α4β7 integrin, Janus kinase inhibitors (JAKis) and sphingosine-1-phosphate receptor (S1PR) modulators, do not achieve sustained responses for all patients, leaving significant unmet therapeutic needs.

Methods and analysis

This prospective, multi-centre observational study will follow a cohort of 240 patients across multiple study centres within NHS trusts in the UK who are initiating or switching biologics, specifically anti-TNFα and anti-α4β7 integrin for UC, and anti-TNFα, antibodies to p40 subunit of IL-12/2 and JAKi for CD. Through comprehensive profiling of immunological, transcriptional, microbiome, genetic and proteomic markers at baseline, week 12, and week 52, this study aims to uncover non-invasive biomarkers that predict response to these drug classes, ultimately advancing personalised medicine in IBD.

Ethics and dissemination

Ethical approval for the Nottingham/AstraZeneca study was granted by the West of Scotland Research Ethics Committee. Recruitment began in December 2022 and is currently ongoing at 10 NHS Trust sites across the UK. Study findings will be disseminated by publication in peer-reviewed journals and presentations at relevant national and international conferences.

Knowledge, attitude and practice towards secondary prevention medication regimens among coronary heart disease patients in Shandong Province, China: a multi-centre cross-sectional study

Por: Li · Q. · Dong · M. · Liu · C. · Zhang · T. · Meng · X. · Li · Z. · Zhao · P. · Liu · F.
Objective

Secondary prevention strategies for coronary heart disease (CHD) can play a crucial role in averting acute coronary events and enhancing the overall well-being of CHD patients. This study aimed to investigate the knowledge, attitude and practice (KAP) of CHD patients in Shandong Province, China, toward secondary prevention medication regimens for CHD.

Design

A multi-centre cross-sectional study.

Setting

Using a self-administered questionnaire.

Participants

This survey was conducted between October 2023 and February 2024 across four tertiary hospitals in Shandong Province, including the Provincial Hospital Affiliated with Shandong First Medical University, Qilu Hospital of Shandong University, Jinan Central Hospital and Jinan Fourth People’s Hospital.

Primary and secondary outcome measures

The KAP of CHD patients toward secondary prevention medication regimens.

Results

A total of 495 participants were finally enrolled, 347 (70.1%) were male and 248 (50.1%) were aged greater than or equal to 65 years. The mean score of KAP was 6.73 (5.19) (range: 0–20), 29.15 (3.81) (range: 7–35) and 28.61 (3.90) (range: 7–35), respectively. The structural equation model demonstrated that knowledge had a direct effect on attitude (β=0.427, p

Conclusions

CHD patients demonstrated insufficient knowledge, positive attitude and proactive practice toward secondary prevention medication regimens for CHD. It is recommended that healthcare providers implement targeted educational interventions to enhance patients’ knowledge levels regarding secondary prevention medication regimens for CHD.

❌