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Promising solution for standardised length of hospital stay based on time-to-event models and contemporary Australian administrative data

Por: Duke · G. J. · Hirth · S. · Santamaria · J. D. · Li · Z. · Read · C. · Hamilton · A. · Lapiz · E. · Le · T. · Fernando · T. · Merlo · R.
Objective

Hospital length of stay (LOS) is a key indicator of hospital efficiency and quality of care, but a reliable metric for benchmarking LOS remains problematic. This report describes a time-to-event methodology to generate a hospital standardised LOS ratio (HSLR).

Design

Retrospective observational analysis of LOS from a jurisdictional administrative dataset using a time-to-event (hazard of discharge) analytic approach to generate risk-adjusted LOS (predicted LOS—pLOS), and the HSLR (= (sum observed LOS)/(sum total pLOS)).

Setting

219 (public and private) acute-care hospitals in the State of Victoria, Australia, adult population 5.28 million.

Participants

2.73 million adult multiday separations and 15.53 million bed-days from July 2019 to June 2024.

Interventions

Nil.

Outcome measures

Descriptive statistics for annual mean LOS (aLOS), pLOS and HSLR at the hospital level with model fit assessed for calibration (Cox-Snell residuals), classification (aLOS and HSLR results for hospital-years compared to benchmark), variance (intraclass correlation coefficient (ICC) at provider level) and model dispersion (value () and random effect SD ()) characteristics.

Results

Observed LOS was markedly right skewed and autocorrelated (p3 SD of benchmark); whereas 936 (99.5%) HSLR values were inliers (

Conclusions

aLOS is a simple descriptor but poor comparator. Time-to-event survival analytic models furnish risk-adjusted pLOS and HSLR metrics which indicate that the majority of LOS variation is due to patient-related, not hospital, factors.

Percutaneous coronary intervention, coronary artery bypass grafting and mortality from acute myocardial infarction in EU15+ countries, 2006-2020: a secondary analysis of the OECD database

Por: Ojha · U. · Marshall · D. C. · Hammond-Haley · M. · Salciccioli · J. D. · Shalhoub · J. · Hartley · A.
Objective

Coronary revascularisation practices have evolved over the last three decades. This study sought to examine the variations in percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) rates, alongside mortality from acute myocardial infarction (AMI) across a group of 16 high-income countries between 2006 and 2020.

Design

Retrospective observational analysis using data from the Organisation for Economic Co-operation and Development (OECD) database between 2006 and 2020. Estimated annual percent change in revascularisation was analysed using Joinpoint regression model, and mortality rates were evaluated using the locally weighted scatterplot smoothing model.

Setting

Publicly available data on PCI and CABG procedure rates alongside AMI mortality rate from 2006 to 2020.

Participants

16 countries from the OECD database.

Interventions

Not applicable.

Main outcome measures

Standardised PCI and CABG procedure rates and AMI age-standardised mortality rate (ASMR) from 2006 to 2020.

Results

Over the 15 year period, 14.0 million PCI and 2.8 million CABG procedures were collectively recorded across 16 countries. PCI rates varied among nations, but from 2006 to 2020 increased in 11 of the 16 nations overall, led by Finland (+36.0%), Ireland (+34.5%) and France (+31.5%). Meanwhile, CABG rates declined in 14 out of the 16 countries, with Luxembourg (–71.3%), the UK (–62.6%) and Finland (–60.6%) experiencing the most substantial decreases. Throughout the study period, the PCI-to-CABG ratio increased, while AMI ASMR decreased consistently across all countries.

Conclusions

Despite evidence supporting CABG over PCI in specific scenarios, CABG rates have declined, and PCI rates have increased. Possible factors for this trend may include patient preference and advancement in interventional techniques. The varied use of PCI among these nations, alongside a sustained decline in AMI mortality rates, may be expected given the importance of optimal medical therapy in the management of ischaemic heart disease. The results further suggest the significance of factors beyond revascularisation in driving improved outcomes.

Influence of subnational contextual factors on demand for family planning satisfied by modern methods: a multilevel approach in 46 surveys from low- and middle-income countries

Por: Lima · N. P. · Blumenberg · C. · Hellwig · F. · Barros · A. J. D. · Wehrmeister · F. C.
Objectives

Understanding contextual drivers of family planning is crucial for designing effective, context-specific policies and programmes. This study aimed to assess (1) the extent to which province-level contextual factors are associated with both coverage and wealth-related inequalities in demand for family planning satisfied by modern methods (mDFPS) across provinces in low- and middle-income countries (LMICs), and (2) whether these factors influence mDFPS at women’s level.

Design

Observational study using multilevel modelling at both ecological and individual levels.

Setting

We analysed data from Demographic and Health Surveys between 2011 and 2022 in 46 LMICs.

Participants

Ecological analysis included 621 provinces. Individual-level analysis included 302 493 women aged 15–49 years, currently married or in union, and in need of contraception (unweighted).

Primary and secondary outcome measures

Demand for family planning satisfied by modern methods (mDFPS) and wealth-related inequalities in mDFPS, assessed using the slope index of inequality (SII) and the concentration index (CIX).

Results

In both income groups, at the province level, higher mean women’s schooling and greater proportion of employed women were positively associated with mDFPS coverage. In contrast, higher male-to-female educational attainment ratios were inversely associated with mDFPS. Provinces with higher means of women’s schooling also showed lower wealth-related inequalities in mDFPS. At the individual level, women residing in provinces with higher male-to-female educational attainment ratios were found to have lower odds of mDFPS, regardless of the income group. Additionally, the factors influencing individual women’s mDFPS varied depending on the income level of the country’s provinces.

Conclusion

Women’s empowerment and gender equality in education at the province level significantly influence family planning outcomes. Targeted interventions that address each region’s specific educational, economic and demographic contexts are crucial for improving coverage and reducing disparities in family planning services.

Barriers and strategies for pain management in non-verbal people with dementia in residential care facilities: protocol for an e-Delphi study

Por: Felix · I. B. · Ramos · C. · Guerreiro · R. · Hughes · J. D. · Hoti · K. · Andrade · T. · Guerreiro · M.
Introduction

Pain is a prevalent symptom in people living with dementia. Evidence shows that pain frequently remains unrecognised and untreated in this vulnerable population, leading to avoidable suffering. Effective pain management is hindered by multifactorial barriers at the individual, organisational and policy level. This study aims to achieve expert consensus on the key barriers to pain management in non-verbal people living with dementia and strategies to address these barriers within Portuguese residential care facilities.

Methods and analysis

An e-Delphi study will be conducted using two rounds of online questionnaires. The Behaviour Change Wheel (BCW) framework guided the development of e-Delphi statements by linking identified determinants (i.e., barriers and facilitators) to intervention functions. Barriers were extracted from the literature reviews and mapped into the capability, opportunity and motivation–behaviour model. Intervention functions were then selected using the BCW linkage matrices and operationalised into practical strategies. A purposive and snowball sampling approach will be used to recruit a heterogeneous panel of experts across national residential care facilities, including nurses, physicians, managers and policymakers with relevant experience in dementia. During the e-Delphi rounds, participants will be invited to rate the relevance of each barrier and associated strategy(ies) on a five-point Likert scale and provide comments or suggestions. Consensus will be defined as ≥75% agreement on each statement.

Ethics and dissemination

Ethical approval for this study was obtained from the Egas Moniz Ethics Committee (Ref. 1586), and all procedures will comply with the Declaration of Helsinki. Informed consent will be obtained from all participants. The findings will be disseminated through a peer-reviewed publication, scientific events and stakeholder networks, including residential care facilities, to inform future practice and policy in dementia care.

Feasibility of an AI-assisted transcranial duplex sonography protocol for early detection of intracerebral haemorrhage: the HYPER-AI-SCAN single-centre prospective study

Por: Simonetti · R. · Canals · P. · Gonzalez Riveros · J. D. · Alanis-Bernal · M. · Pancorbo · O. · Rodriguez-Luna · D.
Introduction

Intracerebral haemorrhage (ICH) is associated with high early mortality and morbidity. Early clinical deterioration is common and influenced by haematoma expansion, which can occur within the first hours after symptom onset. Transcranial duplex sonography (TCD) is a rapid, non-invasive tool that may aid in early ICH detection but is highly operator-dependent. Artificial intelligence (AI)-based analysis of ultrasound images has shown promise in other fields but has not yet been validated in acute ICH.

Methods and analysis

This is a single-centre, prospective feasibility study involving 500 patients with acute ischaemic and haemorrhagic stroke (

Ethics and dissemination

Ethical approval has been obtained. Informed consent will be collected. Data will be coded and stored securely. Results will be disseminated through peer-reviewed journals and conferences.

Trial registration number

Not applicable at this stage (observational AI study).

COVID-19 antibody testing study: a nested substudy within Albertas Tomorrow Project (ATP) in Alberta, Canada

Por: Nejatinamini · S. · Charlton · C. · Harman · S. · Kanji · J. N. · Kellner · J. D. · Lines · K. · Murdoch · K. · Powell · W. · Roberts · J. · Rosner · W. · Shen-Tu · G. · Tipples · G. · Xu · J.-Y. · Vena · J. E.
Purpose

The Alberta’s Tomorrow Project (ATP) prospective cohort study was established in 2000 to investigate the causes of cancer and chronic disease. The cohort consists of almost 55 000 participants aged 35–69 years at the time of recruitment. From 2020 to 2022, ATP conducted a longitudinal substudy, the COVID-19 Antibody Testing (CAT) study, nested in this existing cohort, to understand the spread and impact of the SARS-CoV-2. In this cohort profile, we describe the CAT study design, recruitment and initial findings.

Participants

In this prospective cohort substudy, ~4000 participants completed online surveys and provided blood samples at a study centre every 4 months for 1 year, across four cities in Alberta, Canada. The study was launched on a rolling basis beginning in September 2020 and data collection was completed in May 2022. The surveys collected information on health and lifestyle factors, COVID-19 (testing, symptoms, vaccination, public health recommendations) and impacts of the pandemic (including economic, health services, mental health). Blood samples were tested for antinucleocapsid and antispike protein SARS-CoV-2 antibodies.

Findings to date

A total of 4102 participants consented and attended a study centre at baseline, and almost 90% of these completed the study. Overall, participants were aged 61±10 years, 60% female, 12% came from rural areas, 45% had at least a bachelor’s degree, 24% reported a household income 4 weeks). By the end of the study, 96% of participants had received at least one COVID-19 vaccine dose. Through investigating other outcomes, it was observed that participants under 50 years of age were more likely to be assessed to have mild or moderate-to-severe anxiety and depressive symptoms compared with older participants. In addition, approximately 15% of participants reported a moderate to major impact on their ability to meet financial obligations.

Future plans

Serology results, together with health, lifestyle and sociodemographic data, and the continued follow-up of these participants as part of the broader ATP cohort study (planned through 2065), will provide opportunities to investigate the long-term sequelae of COVID-19 infection as well as the broader impacts of the pandemic on physical, mental and emotional health. Data are available to researchers on request through the ATP access process.

Emerging concepts and practices in health disparities implementation science in the United States: a scoping review protocol

Por: Earland · D. E. · Andreae · L. J. · Austin · J. D. · Gollust · S. E. · Japuntich · S. J. · Theis-Mahon · N. · Reardon · E. · Abdikeir · K. · Crusan · A. · Overcash · F. · Allen · M. L.
Introduction

Implementation science research increases the uptake of evidence-based interventions, which may improve health equity among racial and ethnic minorities. However, it is unclear how anti-racism and anti-colonialism practices have been integrated into implementation science research. The objectives of this scoping review are to describe the current conceptualisations of racism and colonialism within the USA, examine racism or colonialism-conscious approaches and analyse gaps in the operationalisation of anti-racism or anti-colonialism within implementation science studies.

Methods and analysis

This scoping review will be conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews guidelines. The Center for Chronic Disease Reduction and Equity Promotion Across Minnesota conceptual framework and an implementation science anti-racism lens will guide the study design and analysis. To determine study eligibility for the scoping review, articles will undergo abstract and full-text screening by two independent reviewers and discrepancies will be settled together. Data charting will be extracted from included articles by eight independent reviewers. The search strategy will use controlled vocabulary and natural language keywords related to health equity, health disparities and anti-racism/colonialism on six databases. The scoping review will include studies that applied implementation science theories, models or frameworks among US-based populations. Additionally, included studies will report any of the following implementation activities: implementation strategies, implementation outcomes, adaptations to evidence-based interventions, or evaluations of pre-implementation or implementation context.

Ethics and dissemination

No ethical approval was required for the scoping review. Dissemination will be through publication in a peer-reviewed journal and conference presentations.

Pragmatic paradigm for patient-reported outcome measure selection in lymphoma clinical trials: a rapid review study

Por: Guo · J. D. · Hartzema · A. · Cohen · J. B. · Tunstall · N. · Gehchan · A.
Objectives

Lymphoma is a haematologic malignancy affecting cells of the immune system. With numerous treatment options available, clinicians and patients frequently face difficulty in selecting the most appropriate therapy. Patient-reported Outcome (PRO) offers valuable patients’ insight that may support treatment differentiation. A PRO measure (PROM) is a questionnaire or survey measuring a PRO. Despite many efforts to guide the selection of PROMs in clinical trials, choosing the appropriate ones remains a challenge. This study aims to develop a pragmatic paradigm for selecting PROMs in clinical trials involving adult patients with lymphoma through the collaboration and communication between clinical investigators involved in trials and Health Economics and Outcomes Research (HEOR) scientists specialised in research methodologies.

Design

A rapid review was conducted to identify existing PROMs for adult patients with lymphoma in clinical trials and guidelines supporting PROM selection.

Data sources

PubMed, Google Scholar and websites for regulatory and health technology assessment (HTA) bodies in eight countries of interest were searched from 2009 to July 2024.

Eligibility criteria

Publications with PROMs were identified for adult patients in lymphoma trials. The most relevant guidelines supporting the development of the pragmatic paradigm were selected.

Data extraction and synthesis

The initial search and data extraction were conducted by one author. All authors participated in an in-depth review process.

Results

We categorise 31 applicable PROMs for lymphoma into four distinct groups, streamlining the PROM selection process to facilitate effective communication among clinical investigators, HEOR scientists, patients and others. Additionally, a five-step pragmatic paradigm is developed for identifying appropriate PROM(s).

Conclusions

The pragmatic paradigm presents a practical approach for selecting PROM(s) in lymphoma clinical trials. An appropriate PROM should conceptually align with the treatment goals and be acceptable to regulatory and HTA bodies. Thus, lymphoma clinical trials can generate more patient-focused data, contributing to improving patients’ quality of life and advancing lymphoma care.

Community participatory approaches in infectious disease dynamic transmission modelling: a scoping review protocol

Por: Tahmo · N. B. · Idemili · C. · Noah · A. · Odhiambo · B. · Kyalo · C. · Ligare · F. · Wanjiku · J. · Kong · J. D. · Chan · A. K. · Baral · S. · Walimbwa · J. · Lazarus · L. · Puchalski Ritchie · L. M. · Mishra · S.
Introduction

Community participatory modelling merges participatory research approaches with mathematical modelling. Participatory approaches are grounded in the engagement of people with lived experience (eg, who are affected by the health condition under study) throughout the research process. Mathematical modelling of infectious disease (ID) dynamic transmissions is increasingly used as a tool for public health decision-making, generating predictions, inferring mechanisms and estimating the impact of potential interventions—all of which guide policies, strategies and resource allocation as part of the preparation and response to ID epidemics. However, little is known about the engagement of people with lived experience and affected communities in the ID modelling process. We will map the literature to explore participatory approaches undertaken in ID modelling (practical aspects of formalising participatory modelling), levels of participation and the potential influence from the perspective of communities engaged.

Methods and analysis

The scoping review will follow the Joanna Briggs Institute Manual for Evidence Synthesis. The search strategy includes three electronic bibliographic databases (MEDLINE, Scopus and Embase), no language restrictions and sources published from 2000 to present. We will implement the search with and without the participatory keyword, as we recognise that some studies do not explicitly term community engagement as participatory modelling. After deduplication, two authors will independently screen the titles, abstracts and full texts, with discrepancies resolved with a third team member. We will extract the relevant information from the main text, parameter tables, supplemental files, bibliography, acknowledgment and author affiliation sections. The data extraction will follow a deductive content analysis where we draw from community-based participatory research approaches and established mathematical modelling steps. We will also extract data to assess whether there was equitable engagement of knowledge users by checking for indicators of three equitable engagement domains as outlined by the Ward framework (equity within partnership (eg, whether knowledge user influenced modelling decisions or remuneration), capacity to engage in future partnerships and shift in power/influence (eg, coauthorship). We will supplement our narrative analyses with summaries in tabular format and using appropriate data visualisations.

Ethics and dissemination

No ethics approval will be required for this scoping review because we will map evidence from publicly available literature sources. We will develop multilingual abstracts or one-page lay summaries of the findings (English, French and Swahili), a policy brief and will coauthor an open-access journal article. A summary of the findings will be shared via knowledge user-led presentations at the Maisha HIV and AIDS Conference and with other community-based organisations at the quarterly peer-to-peer support meetings.

Registration

The protocol has been registered in Open Science Framework, DOI: https://doi.org/10.17605/OSF.IO/XQ2WP (December 2024).

Evaluating a co-created model for video consultations in cardiac rehabilitation: impact on health literacy, quality of life and family support--a study protocol

Por: Rosenstrom · S. · Cecilie Tjustrup · N. · Kallemose · T. · Risom · S. S. · Hove · J. D. · Brodsgaard · A.
Introduction

Cardiac rehabilitation has traditionally been administered through face-to-face consultations with a specialised team of nurses, medical doctors and physiotherapists. However, the healthcare system is undergoing a significant digital transformation, which may lead to telemedicine (TM) becoming a cornerstone of healthcare. However, successful TM requires digital competencies among both patients and health professionals. This trial will examine the best methods of onboarding patients to TM by way of a co-designed cardiac telerehabilitation model with a family-focused approach.

Aim

The aim is to investigate how patients and family members could benefit from using TM, including video consultations and home monitoring, for cardiac rehabilitation. We ask how patients’ health literacy, digital health literacy, health-related quality of life and family support would be affected by a shift to TM.

Methods and analysis

The primary outcome is the Health Literacy Questionnaire, and secondary outcomes are the eHealth Literacy Questionnaire, European Quality of Life—Five Dimensions Scale, and the Iceland—Family Perceived Support Questionnaire. The sample size is 73 patients in each group. Data will be analysed with 2 or Fisher’s exact tests, a t-test or a Wilcoxon signed-rank test, depending on the distribution.

Ethics and dissemination

Approval for this trial was obtained from the Danish Data Protection Agency (P-2023-65) and the National Committee on Health Research Ethics (F-23075094). The trial will be conducted in compliance with the Declaration of Helsinki. The trial results—whether positive, neutral or negative—will be submitted for publication. The trial has been registered at ClinicalTrials.gov (NCT06320652).

Trial registration number

(NCT06320652).

MINMON-J: a hybrid implementation pilot study evaluating a low-barrier hepatitis C treatment model in a jail setting

Por: Berk · J. · Fu · E. S. · Murphy · M. · Akiyama · M. J. · Sulkowski · M. · Rich · J. D. · Frank · H. E.
Introduction

Hepatitis C virus (HCV) remains a leading cause of infectious disease-related morbidity in the USA, disproportionately affecting people who inject drugs and people who are incarcerated. Despite the availability of highly effective, highly tolerated direct-acting antivirals, treatment uptake in jails remains limited due to short stays, unpredictable release dates and system-level barriers. The original MINMON trial demonstrated that a low barrier ‘minimal monitoring"’ model can achieve high cure rates in community settings. This study, MINMON-J, aims to adapt and evaluate a modified version of the MINMON model for use in a jail setting, addressing the urgent need for scalable, low-barrier treatment approaches among justice-involved individuals.

Methods and analysis

MINMON-J is a single-arm, hybrid effectiveness-implementation pilot study protocol planned to recruit at the Rhode Island Department of Corrections. 40 people who are incarcerated with positive HCV RNA, who are treatment-naïve, without cirrhosis and awaiting trial, will receive 12 weeks of sofosbuvir/velpatasvir with no required lab monitoring during treatment. If released before treatment completion, participants will receive their remaining medication at discharge. Community health workers will provide post-release support. Mixed-methods evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance/Practical, Robust Implementation and Sustainability Model framework. Primary outcomes include feasibility, acceptability and adherence. Data will be collected through administrative records, surveys (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Brief Adherence Rating Scale) and qualitative interviews with participants and other relevant parties. This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections Medical Research Advisory Group.

Ethics and dissemination

This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections (RIDOC) Medical Research Advisory Group. All participants will provide written informed consent prior to enrolment. People who are incarcerated will be assured that participation is voluntary, will not impact their clinical care and that they may withdraw at any time without penalty. Study procedures follow ethical principles outlined in the Declaration of Helsinki and comply with federal regulations regarding research involving vulnerable populations.

Dissemination of findings will include peer-reviewed publications and presentations at national conferences focused on infectious diseases, implementation science and/or correctional health. Lay summaries will be shared with RIDOC leadership and community partners. De-identified data and associated metadata may be archived in a publicly accessible repository in accordance with National Institutes of Health data sharing policies, contingent on final institutional review board approval and participant protections.

Trial registration number

NCT06953479.

Cardiovascular effects of incretin-based drugs in patients with and without a history of heart failure: a protocol for a systematic review, meta-analysis and trial sequential analysis of randomised controlled trials

Por: El-Sheikh · M. · Sillassen · C. D. B. · Wisborg · F. D. · Hove · J. D. · Dirksen · C. · Lee · M. M. Y. · Jakobsen · J. C. · Grand · J.
Background

Incretin-based drugs, including glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RAs, are increasingly used in the management of type 2 diabetes mellitus and obesity. While these agents have shown cardiovascular benefits, their effects on both cardiovascular outcomes and cardiac structure and function remain uncertain—particularly in patients with and without a history of heart failure (HF).

Methods and analysis

We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database (EMBASE), Latin American and Caribbean Health Sciences Literature (LILACS), Science Citation Index Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index-Science (CPCI-S)), as well as clinical trial registries from their inception and onwards to identify relevant randomised trials. The literature search is scheduled for July 2025. Two review authors will independently extract data and assess risk of bias. We will include randomised controlled trials assessing the effects of cagrilintide/semaglutide, liraglutide, semaglutide and tirzepatide in patients with and without a history of HF. The primary outcome will be cardiovascular mortality. Secondary outcomes will include HF hospitalisation, myocardial infarction, stroke, heart rate, systolic blood pressure, N-terminal pro B-type natriuretic peptide, left ventricular ejection fraction, left ventricular end-diastolic volume and left ventricular end-systolic volume. Data will be synthesised by aggregate data meta-analyses and trial sequential analysis. Risk of bias will be assessed with the Cochrane Risk of Bias tool, version 2, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations (GRADE).

Ethics and dissemination

As this study is a systematic review based on secondary analysis of published data, ethical approval is not required. Findings will be published in international peer-reviewed scientific journals.

PROSPERO registration number

CRD420251003374.

Developing an approach to enhance recruitment for a cluster-randomised implementation trial: leveraging deliberative participation and credible messengers

Por: Vaughn · V. M. · Horowitz · J. · Gandhi · T. · Neetz · R. A. · Petty · L. · Hersh · A. · Lindenauer · P. · Bernstein · S. J. · Flanders · S. A. · Harrison · J. D. · Smith · J. D. · White · A. T. · Szymczak · J. E.
Objectives

To evaluate an innovative approach to recruit 40 hospitals to a cluster randomised controlled trial (RCT) to improve discharge antibiotic prescribing.

Design

This study describes the design, implementation and impact of a theory-informed recruitment approach for hospitals participating in the Reducing Overuse of Antibiotics at Discharge (ROAD) Home trial.

Setting

An inperson meeting of a quality improvement collaborative of acute care hospitals in the state of Michigan.

Participants

Representatives from acute care hospitals that are part of the Michigan Hospital Medicine Safety Consortium.

Interventions

Small group recruitment sessions that combined deliberative participation and credible messengers to recruit hospitals to participate in a cluster RCT on a single date (1 November 2023).

Primary and secondary outcomes

The primary outcome was the number of hospitals which agreed to participate in the trial. We also assessed participant feedback, effectiveness of recruitment methods and resources required for implementation of this approach.

Results

We recruited 51 (74%) of 69 eligible hospitals. Survey participants reported: sessions made clear the purpose of the trial (94%, 64/68) and time commitment required (87%, 59/68); agreed deliberative participation was helpful (82%, 56/68) and were ‘very satisfied’ with the session (82%, 56/68). Investigators largely reported credible messengers were a positive influence, though this varied across sessions. Hospital recruitment was time intensive, taking 179.5 total person hours. The recruitment process involved 3 months of preparation for the sessions and 2 months of follow-up prior to closing recruitment.

Conclusions

We demonstrated the feasibility and impact of a novel approach to recruit hospitals from an existing collaborative to a cluster RCT using the principles of deliberative participation and credible messengers. While the approach was time-consuming, we achieved success at over-recruiting hospitals in a relatively short period of time. Strategies presented here may assist future trial organisers in implementing hospital-based cluster RCTs.

Trial registration number

The ROAD Home trial is registered on Clinical.Trials.gov (NCT06106204).

Advocates, Academics, Survivors and Clinicians to END Intimate Partner Violence (ASCEND-IPV) initiative: a prospective observational case-control study protocol to identify plasma biomarkers of intimate partner violence (IPV)-caused brain injury (BI)

Por: Harper · M. I. · McKinney · K. · McLennan · C. · Adhikari · S. P. · Ghodsi · M. · Cooper · J. G. · Stukas · S. · Maldonado-Rodroguez · N. · Agbay · A. · Morelli · T. · Nouri Zadeh-Tehrani · S. · Lorenz · B. R. · Rothlander · K. · Smirl · J. D. · Wallace · C. · Symons · G. F. · Brand · J
Introduction

Although as many as 92% of survivors of physical intimate partner violence (IPV) report impacts to the head and/or non-fatal strangulation (NFS) that raise clinical suspicion of brain injury (BI), there are no evidence-based methods to document and characterise BI in this vulnerable population, limited clinical practice guidelines and insufficient understanding about long-term risks for conditions including Alzheimer’s Disease and Related Dementias (ADRD). This leaves most survivors of IPV-caused BI (IPV-BI), overwhelmingly women, without adequate access to medical care and support, safe housing, back-to-school/work accommodations or follow-up care for long-term neurocognitive health. Although traumatic brain injury (TBI) is an established ADRD risk factor, little is known about the attributable risk of ADRD due to IPV-BI, particularly in women.

Methods of analysis

Our overarching objectives are to (1) use plasma biomarkers as novel tools to assist clinicians to improve diagnosis of IPV-BI at the acute, subacute and chronic stages in a manner sensitive to the needs of this vulnerable population and (2) raise awareness of the importance of considering IPV-BI as a potential ADRD risk factor. A prospective observational study funded by the US Department of Defense (HT9425-24-1-0462), Brain Canada (6200) and the Canadian Institutes of Health Research (523320-NWT-CAAA-37499) leverages collaborative research at multiple clinical sites in British Columbia to maximise equity, diversity and inclusion among participants, with a target enrolment of n=600 participants.

The Advocates, Academics, Survivors and Clinicians to END Intimate Partner Violence Biomarkers study, which is predicated on pre-specified research questions, represents one of the most significant community-based studies on plasma biomarkers affected by an IPV-BI incident. Of particular significance is the fact our study uses robust biomarker approaches being applied in the TBI and ADRD fields to determine how the biomarker profile after IPV-BI compares to typical TBI and the early stage of neurodegenerative disorders.

Ethics and dissemination

This study was approved by the University of British Columbia Clinical Research Ethics Board (H24-01990, H22-02241 and H16-02792) and the Island Health Research Ethics Board (H22-03510). Upon publication of primary papers, de-identified data and biospecimens will be made widely available, including the US Federal Interagency Traumatic Brain Injury Research (FITBIR) federated database. Our data and integrated knowledge translation activities with persons with lived experience of IPV-BI and those working in the healthcare sector will be synthesised into co-designed and implemented knowledge tools to improve outcomes for survivors of IPV-BI.

Quality and efficiency of integrating customised large language model-generated summaries versus physician-written summaries: a validation study

Objectives

To compare the quality and time efficiency of physician-written summaries with customised large language model (LLM)-generated medical summaries integrated into the electronic health record (EHR) in a non-English clinical environment.

Design

Cross-sectional non-inferiority validation study.

Setting

Tertiary academic hospital.

Participants

52 physicians from 8 specialties at a large Dutch academic hospital participated, either in writing summaries (n=42) or evaluating them (n=10).

Interventions

Physician writers wrote summaries of 50 patient records. LLM-generated summaries were created for the same records using an EHR-integrated LLM. An independent, blinded panel of physician evaluators compared physician-written summaries to LLM-generated summaries.

Primary and secondary outcome measures

Primary outcome measures were completeness, correctness and conciseness (on a 5-point Likert scale). Secondary outcomes were preference and trust, and time to generate either the physician-written or LLM-generated summary.

Results

The completeness and correctness of LLM-generated summaries did not differ significantly from physician-written summaries. However, LLM summaries were less concise (3.0 vs 3.5, p=0.001). Overall evaluation scores were similar (3.4 vs 3.3, p=0.373), with 57% of evaluators preferring LLM-generated summaries. Trust in both summary types was comparable, and interobserver variability showed excellent reliability (intraclass correlation coefficient 0.975). Physicians took an average of 7 min per summary, while LLMs completed the same task in just 15.7 s.

Conclusions

LLM-generated summaries are comparable to physician-written summaries in completeness and correctness, although slightly less concise. With a clear time-saving benefit, LLMs could help reduce clinicians’ administrative burden without compromising summary quality.

Pay-it-forward and social network distribution to increase doxycycline post-exposure prophylaxis uptake among men who have sex with men and transgender women in China: study protocol for a three-arm randomised controlled trial

Por: Zhao · P. · Xu · W. · Tucker · J. D. · Tang · W. · Weideman · A. M. · Enders · K. · Liang · P. · Huang · S. · Fitzpatrick · T. · Wang · C.
Introduction

Doxycycline postexposure prophylaxis (doxy-PEP) can prevent sexually transmitted infections (STIs) among men who have sex with men (MSM) and transgender women (TGW). STI rates are high among MSM and TGW in China, and implementation strategies are needed to optimise doxy-PEP services. Pay-it-forward and social network distribution approaches may increase uptake of STI services and could increase the uptake of doxy-PEP. We present the protocol for a randomised controlled trial evaluating the effectiveness of pay-it-forward strategies with and without adjunctive social network distribution among MSM and TGW in China.

Methods and analysis

A total of 399 MSM and TGW will be recruited at seven sites in China and randomly allocated in a 1:1:1 ratio to (1) self-pay, (2) pay-it-forward alone or (3) pay-it-forward with adjunctive social network distribution of doxy-PEP. Participants assigned to the self-pay arm can purchase a doxy-PEP packet out-of-pocket. Participants in the pay-it-forward arm will be offered a free doxy-PEP packet and the opportunity to donate to support doxy-PEP for future participants. Participants in the pay-it-forward arm with social network distribution will receive the pay-it-forward intervention as well as additional free doxy-PEP packets to distribute to peers. Those randomised to the self-pay and the pay-it-forward with social network distribution arms (ie, index participants) will receive and distribute referral cards to recruit additional peers (ie, alter participants). Alter participants recruited through the control arm will be referred to the clinic to purchase doxy-PEP. Alter participants recruited through the pay-it-forward with adjunctive social network distribution arm will receive doxy-PEP directly from referring index participants. Both index and alter participants in each arm will be asked to complete a follow-up survey 3 and 6 months after enrolment. The primary outcome will be the proportion of participants who report using doxy-PEP within 72-hours of condomless anal or oral sex on one or more occasions during follow-up.

Ethics and dissemination

Ethical approval was obtained from the ethics review committee of the Dermatology Hospital of Southern Medical University (Approval number: 2023109). The findings will be disseminated in peer-reviewed publications.

Trial registration number

The study has been registered with the Chinese Clinical Trial Registry (trial ID ChiCTR2300074903). Date of registration: 18 August 2023.

What are the factors associated with alcohol, cigarette and marijuana use among adolescents in Africa? Evidence from the Global School-based Health Survey

Por: Pokothoane · R. · Argefa · T. G. · Tsague · J. D. · Mdege · N. D.
Objectives

To provide comprehensive estimates of the prevalence of psychoactive substance use, specifically alcohol, cigarettes and marijuana, and factors associated with their use among school-going adolescents in 25 African countries.

Design and methods

We used a pooled cross-sectional dataset from the publicly available Global School-based Health Survey (GSHS) from 25 African countries. We used descriptive statistics to estimate the prevalence of alcohol, cigarette and marijuana use as well as their dual use among adolescents aged 11–16 years. Additionally, we used logistic regressions to model factors associated with the use of each substance, with adjusted Odds Ratios (aORs) and their 95% Confidence Intervals (CIs) as the measures of association.

Setting and participants

The study focused on school-going adolescents aged 11–16 years in 25 African countries that have conducted the GSHS between 2003 and 2017.

Outcome measures

The key outcome measure is the proportion of adolescents who have used a specific substance in the past 30 days. These substances include: (1) alcohol, (2) cigarettes, (3) marijuana, (4) alcohol and cigarettes, (5) cigarettes and marijuana and (6) alcohol and marijuana.

Results

The prevalence of alcohol use among adolescents was 9.5% (95% CI 8.4% to 10.7%), that of cigarette smoking was 6.2% (95% CI 5.0% to 7.6%), and it was 3.4% (95% CI 2.7% to 4.2%) for marijuana. The prevalence of dual use of alcohol and cigarettes was 3.1% (95% CI 2.4% to 3.9%), that of alcohol and marijuana was 2.0% (95% CI 1.5% to 2.5%), and it was 1.4% (95% CI 1.1% to 1.8%) for cigarettes and marijuana. The prevalence of cigarette smoking was significantly higher among boys than girls. However, there was no statistically significant difference in the prevalence of alcohol or marijuana by sex. Having parents who smoke any tobacco products, being bullied, missing school without permission and experiencing sadness and hopelessness were positively associated with being a current user, irrespective of substance type.

Conclusions

There is a need for comprehensive, current data on substance use among adolescents. Interventions that tackle bullying, reduce school absenteeism, build resilience against difficult situations and increase self-efficacy to resist the use of these substances have the potential to curb substance use among adolescents in Africa.

Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism (PEREGRINE): a protocol for a randomised multiarm surgical pilot trial

Por: Staibano · P. · Au · M. · Pasternak · J. D. · Parpia · S. · Zhang · H. · Busse · J. W. · Nguyen · N.-T. · Monteiro · E. · Gupta · M. K. · Choi · D. L. · Lewis · T. · McKechnie · T. · Thabane · A. · Ham · J. · Young · J. E. · Bhandari · M.
Background

Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT.

Methods/design

Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50–69% modify protocol before proceeding;

Ethics and dissemination

Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals.

Trial registration number

NCT06542315, registered on 6 August 2024.

Enhancing cognitive function in breast cancer survivors through community-based aerobic exercise training: protocol for a Hybrid Type I effectiveness-implementation study employing a randomised controlled design

Por: Ehlers · D. K. · Austin · J. D. · Ernst · B. · Page · L. L. · Ofori · E. · Porter · G. C. · Fanning · J. · Hickman · G. · McKim · P. · Cole · M. · Donaldson · M. · Braden · B. B. · Kunze · K. L. · Butterfield · R. J. · Baxter · L. C. · Ahles · T. A. · Estabrooks · P.
Introduction

Despite growing evidence to characterise cancer-associated cognitive decline (CACD) in women with breast cancer, interventions to mitigate CACD are limited. Emerging evidence suggests aerobic exercise may enhance cognition after breast cancer diagnosis and treatment; yet, CACD remains an understudied outcome of exercise, and few high-quality studies have been conducted. In addition to knowledge gaps in effectiveness, the translation of exercise interventions to community settings remains challenging. The Breast cancer Reasoning and Activity INtervention (BRAIN) investigates the effectiveness of aerobic exercise training, delivered in a community-based setting, for improving cognitive function in women with breast cancer and gathers information on the implementation success of the intervention.

Methods and analysis

This Hybrid Type I effectiveness–implementation study is conducted at an academic medical centre in the southwestern United States in partnership with a non-profit, community health and wellness organisation. The study enrols 160 women diagnosed with stage I–IIIa breast cancer and within 3–36 months of treatment completion into a 1:1 randomised controlled trial. Individuals randomised to the exercise group receive a 6-month, individually tailored aerobic exercise programme delivered by exercise trainers employed at local community fitness centres. The programme is progressive in nature and designed to help participants achieve aerobic exercise levels consistent with guidelines for cancer survivors. Individuals randomise to the control group receive a 6-month health education control intervention delivered virtually by hospital-based health educators. Cognitive performance (primary), self-reported cognition, patient-reported outcomes, physical activity and cardiorespiratory fitness are measured at baseline, 6 months (postintervention) and 12 months (follow-up). Brain structure and function are measured via magnetic resonance imaging (MRI) at baseline and 6 months. Implementation outcomes are defined by the RE-AIM framework, which includes reach, effectiveness, adoption, implementation and maintenance. RE-AIM outcomes are measured at baseline, 6 months, 12 months and ongoing during the study.

Ethics and dissemination

This study was approved by the Mayo Clinic Institutional Review Board (#23-000020). All participants provide informed consent prior to participation. Findings will be disseminated to scientific, clinical and community audiences through manuscripts, presentations and newsletters.

Trial registration number

NCT04816006.

Telenursing practice in the care of patients with surgical cancer: a scoping review

Por: Mozer · C. A. d. N. · Goncalves · J. d. C. · Rozetti · C. M. T. · Carvalho · R. d. · Fiorin · B. H. · Furieri · L. B. · Fioresi · M.
Objectives

Surgical oncology patients often experience doubts and uncertainties in the preoperative and postoperative periods, which can be addressed remotely through telenursing. Expanding telenursing services could contribute to more comprehensive perioperative care. We conducted a scoping review to characterise these telenursing services, identify their outcome indicators and examine the content of the care delivered.

Design

A scoping review was conducted in accordance with the Joanna Briggs Institute (JBI) recommendations.

Data sources

MEDLINE (PubMed), EMBASE, CINAHL, SCOPUS, Web of Science and Virtual Health Library (VHL), with searches performed up to 5 May 2025.

Eligibility criteria for selecting studies

We included studies that implemented telenursing interventions in the preoperative or postoperative period in adult oncology patients.

Data extraction and synthesis

Two independent reviewers used a standardised search to select and extract data from the included studies. Study characteristics were presented descriptively using absolute and relative frequencies, and the content of telenursing interventions was organised into a circular thematic matrix.

Results

A total of 37 studies were included, published between 1996 and 2024, conducted in 12 countries and primarily focused on postoperative telenursing via telephone or video calls. Preoperative care focused on psychosocial support and guidance related to surgical preparation. Postoperative topics included surgical wound care; handling of devices such as drains, ostomy bags and catheters; instructions for returning to work and support groups for financial and social assistance. Outcome indicators were primarily related to care, including levels of anxiety, stress, depression and quality of life.

Conclusions

Oncologic surgical telenursing remains primarily focused on postoperative care and the delivery of personalised support. Reporting on the protocols used, frequency and duration of sessions, nurse training and profiles, integration with in-person care workflows and operational cost data could strengthen the knowledge base for perioperative telenursing in oncology.

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