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Ayer — Octubre 2nd 2025Tus fuentes RSS

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.

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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.

Peer support enhanced behavioural crisis response teams in the emergency department: protocol for a stepped-wedge cluster-randomised controlled trial

Por: Nath · B. · Desai · R. · Cook · J. M. · Dziura · J. D. · Davis-Plourde · K. · Youins · R. · Guy · K. · Pavlo · A. J. · Smith · P. E. · Smith · P. D. · Kangas · K. · Heckmann · R. · Hart · L. · Powsner · S. · Sevilla · M. · Evans · M. · Kumar · A. · Faustino · I. V. · Hu · Y. · Bellamy · C. · W
Introduction

Despite expert recommendations to prioritise non-invasive and patient-centred approaches for behavioural crisis management, physical restraints are commonly used in the emergency department (ED). Patients describe the restraint process as coercive and dehumanising. The use of peer support workers, who are individuals with lived experience of mental illness and behavioural conditions, has shown positive patient outcomes when assisting individuals experiencing behavioural crises. However, there is limited evidence of the implementation of such an approach in the ED setting. The goal of this study is to evaluate if the implementation of a Peer support enhanced Agitation Crisis response Team (PACT) for behavioural crisis management in the ED is more effective than usual care to reduce restraint use and improve outcomes among patients presenting to the ED with behavioural crises.

Methods and analysis

We will first conduct a stakeholder-informed needs assessment to codesign the protocol and then train staff and peers in PACT intervention readiness. Next, a stepped-wedge, cluster-randomised controlled trial will be conducted over 3 years at five ED sites across a healthcare system in the Northeast USA. The PACT intervention will integrate peer delivery of trauma-informed care within a structured, interprofessional, team-based response protocol for behavioural crisis management. The primary outcome is the rate of physical restraint and/or sedation use. The secondary outcome is the level of patient agitation during the ED visit. Analyses of primary and secondary outcomes will be conducted using generalised linear mixed models.

Ethics and dissemination

This protocol has been approved by the Yale University Human Investigation Committee (protocol number 2000037554). The study is deemed minimal risk and has been granted a waiver of consent for trial participants. However, verbal consent will be obtained for a subset of patients receiving follow-up data collection. Results will be disseminated through publications in open-access, peer-reviewed journals, via scientific presentations, or through direct mail notifications.

Trial registration number

Clinicaltrials.gov: NCT06556069.

Balancing burden and bond: challenges and motivations of family caregivers of patients with end-stage liver disease in Northern Ghana--a qualitative inquiry

Por: Dogtir · J. D. · Adjei · C. A. · Kyei · J. M. · Ani-Amponsah · M. · Marfo · E. A. · Asirifi · M. A.
Objective

This study explored the burdens and motivations of family caregivers (FCs) for patients with end-stage liver disease (ESLD) in a tertiary hospital in Ghana.

Design

A qualitative exploratory, descriptive approach with a purposive sampling technique was adopted. Data were collected through face-to-face semi-structured interviews. The interviews were audio-recorded, transcribed verbatim and analysed using content analysis.

Setting

Participants were recruited from a tertiary hospital in the Northern Region of Ghana.

Participants

15 FCs aged between 18 and 50 years caring for patients with ESLD were recruited.

Results

The study’s findings revealed that FCs of individuals with ESLD encountered considerable challenges, including sleep deprivation, physical exhaustion, family conflicts, financial difficulties and social restrictions. These difficulties contributed to a sense of being overwhelmed as caregivers strived to fulfil their duties. Family bonds, reciprocal relationships and religious obligations were the motivation/driving force for FCs caring for relatives with ESLD.

Conclusion

Integrating palliative care services in tertiary health facilities will reduce the burdens FCs of patients with ESLD face. Relevant stakeholders in the health sector need to develop culturally sensitive interventions to support FCs caring for patients with ESLD in Ghana.

Feasibility randomised controlled trial to assess the delivery of a novel isometric exercise intervention for people diagnosed with uncomplicated stage 1 hypertension in the National Health Service: key quantitative findings

Por: Wiles · J. D. · Santer · E. · Rees-Roberts · M. · Borthwick · R. · Doulton · T. · Swift · P. A. · Pellatt-Higgins · T. · Saxby · K. · Mills · A. · Gousia · K. · MacInnes · D. · ODriscoll · J. · West · A. · Darby · J. · Short · V. · Farmer · C. K.
Objectives

The aim of this study was to determine the feasibility of delivering personalised isometric exercise (IE) for people with stage 1 hypertension. Is it feasible to deliver an isometric wall squat intervention in the National Health Service and what sample size is required to conduct an appropriately powered effectiveness randomised controlled trial (RCT)?

Design

Randomised controlled open-label multicentre feasibility study of IE compared with standard care in unmedicated people with stage 1 hypertension.

Setting

Initially, the study aimed to recruit through primary care, but this process coincided with the advent of the COVID-19 pandemic. Therefore, we shifted focus to direct-to-public advertising and delivery in secondary care.

Participants

People with unmedicated stage 1 hypertension aged over 18 able to perform IE were included. Patients were excluded if average home systolic blood pressure (sBP)

Intervention participants were randomised (1:1) to either standard lifestyle advice or an individualised isometric wall squat prescription, performed 4x2-min bouts three times a week for 6 months.

Primary and secondary outcome measures

We assessed deliverability, attrition, adherence and variance in blood pressure (BP) change.

Results

IE was found to be easily deliverable to all participants. At 6 months, 34% had withdrawn. Of those who completed IE, 85% of their sessions were at the correct intensity, meeting our retention criterion for success. Variance in BP change was 14.4 mm Hg. The study was not powered to show a difference in BP between groups; however, BP reductions were seen in the intervention group at all study time points compared with baseline. There were no adverse events related to study participation.

Conclusions

We met our a priori recruitment criteria which allowed us to calculate a sample size (n=542) for a full RCT. The results demonstrate good acceptability and adherence rates to the treatment protocol. Our results show a signal towards a consistent sBP reduction in the IE group compared with baseline.

Trial registration number

NCT04936022 (https://classic.clinicaltrials.gov/ct2/show/NCT04936022?cond=isometric+exercise&draw=2&rank=7); registry identifier: ISRCTN 13472393.

Primary care providers experience and satisfaction with personalised breast cancer screening risk communication: a descriptive cross-sectional study

Por: Omeranovic · A. · Lapointe · J. · Fortier · P. · Bergeron · A.-S. · Dorval · M. · Chiquette · J. · Boubaker · A. · Eloy · L. · Turgeon · A. · Lambert-Cote · L. · Joly · Y. · Brooks · J. D. · Walker · M. J. · Stockley · T. · Pashayan · N. · Antoniou · A. · Easton · D. · Chiarelli · A. M.
Objective

To describe primary care providers’ (PCPs) experience and satisfaction with receiving risk communication documents on their patient’s breast cancer (BC) risk assessment and proposed screening action plan.

Design

Descriptive cross-sectional study.

Setting

A survey was distributed to all 763 PCPs linked to 1642 women participating in the Personalized Risk Assessment for Prevention and Early Detection of Breast Cancer: Integration and Implementation (PERSPECTIVE I&I) research project in Quebec, approximately 1–4 months after the delivery of the risk communication documents. The recruitment phase took place from July 2021 to July 2022.

Participants

PCPs.

Main outcome measures

Descriptive analyses were conducted to report participants’ experiences and satisfaction with receiving risk communication. Responses to two open-ended questions were subjected to content analysis.

Results

A total of 168 PCPs answered the survey, from which 73% reported being women and 74% having more than 15 years of practice. Only 38% were familiar with the risk-based BC screening approach prior to receiving their patient risk category. A majority (86%) agreed with the screening approach and would recommend it to their patients if implemented at the population level. A majority of PCPs also reported understanding the information provided (92%) and expressed agreement with the proposed BC screening action plan (89%). Some PCPs recommended simplifying the materials, acknowledging the potential increase in workload and emphasising the need for careful planning of professional training efforts.

Conclusion

PCPs expressed positive attitudes towards a risk-based BC screening approach and were generally satisfied with the information provided. This study suggests that, if introduced in Canada in a manner similar to the PERSPECTIVE I&I project, risk-based BC screening would likely be supported by most PCPs. However, they emphasised the importance of addressing concerns such as professional training and the potential impact on workload if the approach were to be implemented at the population level. Future qualitative studies are needed to further explore the training needs of PCPs and to develop strategies for integrating this approach with the high workloads faced by PCPs.

Association between herpes simplex virus 1 and dementia: a systematic review protocol

Por: Hong · A. T. · Luu · I. Y.-K. · Lin · F. · Vij · A. P. · Lewis · K. A. · Wilson · M. L. · Klausner · J. D.
Introduction

Herpes simplex virus 1 (HSV-1) infects approximately two-thirds of the global population under the age of 50 years. Although widely prevalent, the possible implications of HSV-1 in neurodegenerative diseases, especially dementia and Alzheimer’s disease, remain poorly understood. This review seeks to elucidate this association and explore the potential benefits of preventing or treating herpesvirus infections on dementia risk. The goal is to enhance our understanding of HSV-1’s potential role in dementia, which could inform the development of future therapeutic interventions for these conditions.

Methods and analysis

PubMed, Embase (Elsevier/Ovid), Web of Science, Scopus, Global Health, PsycInfo, Cochrane Library and Clinicaltrials.gov will be searched from the inception of each respective database. Studies that have HSV-1 as an exposure and dementia, or its subtypes, as a primary outcome will be included. Two researchers will independently screen titles, abstracts and full texts, with discrepancies resolved by a third researcher. Systematic data extraction from eligible studies will be performed using a standardised template. Risk of bias of individual studies will be assessed with the Cochrane Collaboration approach. We will assess the overall quality of cumulative evidence using the Grading of Recommendations, Assessment, Development and Evaluations criteria. Statistical analysis will employ a random effects model, and heterogeneity will be determined with Cochrane’s Q test and assessed using I2. Studies will be grouped by population subgroups and dementia subtypes when possible to explore nuances in results. We will consider performing meta-regression if heterogeneity remains after subgroup analyses. All statistical analyses will be conducted using Stata V.18 software (College Station, Texas, USA).

Ethics and dissemination

No ethical approval is required since data will be collected from existing studies. The review will be disseminated through peer-reviewed publication and at national and international conferences.

PROSPERO registration number

CRD42024516789.

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