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Ayer — Junio 14th 2026Tus fuentes RSS

Effects of Erbium:YAG laser combined with vaginal estriol therapy in postmenopausal women with Genitourinary Syndrome of Menopause: protocol for a randomised, double-blind, controlled trial

Introduction

Genitourinary syndrome of menopause (GSM) is a chronic, oestrogen-deficient condition that is frequently underdiagnosed and undertreated. Although low-dose vaginal estriol improves epithelial trophism and microbial balance, a substantial proportion of women report persistent symptoms. High-quality randomised evidence evaluating combined therapeutic strategies remains scarce. Energy-based modalities, including the erbium:YAG (Er:YAG) laser (=2940 nm), have been proposed as adjunctive treatments. This trial aims to assess the efficacy of Er:YAG laser therapy combined with vaginal estriol compared with estriol alone in postmenopausal women with GSM.

Methods and analysis

This is a single-centre, randomised, double-blind, controlled clinical trial. Postmenopausal women aged 45–70 years with vaginal pH ≥5.0 and at least one moderate GSM symptom (Visual Analogue Scale ≥4) will be eligible. Exclusion criteria include current systemic or local hormone therapy, previous vaginal energy-based treatment, abnormal cervical cytology and body mass index ≥35 kg/m2. All participants will receive vaginal estriol cream (0.5 mg per dose) daily for 14 days, followed by twice-weekly administration for 16 weeks. Participants will be randomised (1:1) to receive either estriol plus sham Er:YAG laser or estriol plus active Er:YAG laser. Three laser sessions will be delivered at approximately 4-week intervals. Assessments will occur at baseline, monthly during treatment and 4 months after the final session. The primary outcome is the Vulvovaginal Health Index, with the primary endpoint defined as the change from baseline to 4 months post-treatment, reflecting sustained effect. Secondary outcomes include GSM symptom severity, vaginal microbiome composition (16S rRNA sequencing), quality of life (Menopause Rating Scale) and sexual function (Female Sexual Function Index). Data will be analysed using repeated-measures analysis of variance or appropriate non-parametric tests, with significance set at p

Ethics and dissemination

Ethical approval has been obtained from the Human Research Ethics Committee of UNINOVE. Written informed consent will be obtained. Findings will be disseminated via peer-reviewed journals and scientific meetings.

Trial registration number

NCT06873971.

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Treatable Traits for Asthma Management in Pregnancy (TTAP): protocol for an Australian multicentre prospective observational cohort study

Por: Grehan · J. E. · Bristow · J. · Steel · K. · Brew · B. K. · Peek · M. J. · Robijn · A. L. · Barrett · H. L. · Seeho · S. · Fotheringham · P. · Atchan · M. · Harvey · S. M. · Samuel · S. R. N. · McDonald · V. M. · Jensen · M. E. · Holliday · E. G. · Rees · M. · Elvidge · E. · Vining · L.
Introduction

Asthma is one of the most prevalent long-term health conditions affecting pregnant women. Poorly controlled asthma during pregnancy is associated with adverse maternal and fetal outcomes and may predispose offspring to long-term respiratory morbidity. The current ‘one size fits all’ approach to asthma management during pregnancy is not optimally effective for approximately half of the pregnant women with asthma. A personalised medicine approach to managing airways disease is required. The treatable traits approach focuses on the identification and treatment of traits in the pulmonary, extra-pulmonary and behavioural domains, which are identifiable, measurable, clinically relevant (linked to exacerbation risk or poor asthma control) and treatable. This manuscript outlines the protocol for the Treatable Traits for Asthma Management in Pregnancy (TTAP) study. The purpose of the TTAP study is to prospectively determine the prevalence of a range of treatable traits from these three domains in pregnant women with asthma and determine which traits are associated with exacerbation risk, poor asthma control and poor asthma-related quality of life. Additionally, this study will assess differences in trait prevalence and clinical relevance in pregnant women from regional versus metropolitan hospitals in Australia and in different antenatal models of care.

Methods and analysis

The TTAP study is a multicentre, prospective observational cohort study. Study participants are pregnant women with asthma attending antenatal clinics at 10 metropolitan and regional hospitals (public and private) in NSW and Victoria, Australia. Assessment of traits from the pulmonary, extrapulmonary and behavioural domains as well as asthma outcomes is conducted at three gestational timepoints: 12–16 weeks, 22–26 weeks and 32–36 weeks of pregnancy. A follow-up assessment of asthma outcomes is conducted at 2–4 weeks postpartum. The outcomes assessed are asthma exacerbations requiring medical intervention (primary outcome), asthma symptom control and asthma-related quality of life. Traits and outcomes will be assessed using questionnaires, direct questioning, measurement of biomarkers, physical measurements and assessment of routinely collected data from medical records.

Ethics and dissemination

The Hunter New England Human Ethics Committee (2024/ETH01289) has approved the TTAP study protocol. Outcomes will be published in peer-reviewed journals, presented at scientific conferences and disseminated online to participants, clinicians and other pregnant women with asthma and their families via the Asthma in Pregnancy Toolkit website https://asthmapregnancytoolkit.org.au/.

Underlying aetiology of acute intracerebral haemorrhage and associations between outcome measures, findings on initial computed tomography scan and ICH classification systems: an observational historical cohort study

Por: Nielsen · V. · Nielsen · T. · Petersen · S. R. · Andrade Melchiori · F. · Dreis · S. K. R. · Bitterling · H. · Braad · P.-E. · Stenager · E. · Mamoei · S.
Introduction

Intracerebral haemorrhage (ICH) accounts for approximately 15% of all strokes in Denmark and remains associated with high mortality and morbidity. It is challenging to distinguish neoplastic from non-neoplastic causes of ICH in the acute setting, and CT findings that may aid early differentiation have not been fully characterised. Existing ICH-classification systems (SMASH-U, H-ATOMIC and CLAS-ICH) have not been directly compared for diagnostic accuracy in this setting. Identifying radiological and clinical factors associated with underlying aetiology may support faster diagnosis, reduce time to workup related to potential underlying cancer and facilitate early targeted treatment of the underlying cause of ICH.

Methods and analysis

This study is a retrospective observational cohort including all patients admitted with acute ICH to the Department of Neurology, University Hospital of Southern Denmark, Aabenraa between January 2014 and December 2024 (estimated approximately n=610). Medical records and initial non-enhanced CT scans will be reviewed. Two neurologists and two radiologists, blinded to final diagnosis, will independently extract clinical presentation, topographical and volumetric haemorrhage characteristics, and classify each case using the abovementioned ICH-classification systems. Primary analyses will assess associations between clinical and radiological features and underlying neoplastic vs non-neoplastic aetiology. Secondary analyses will compare diagnostic performance of classification systems using sensitivity, specificity and receiver operating characteristic curves. Multivariate logistic regression models will be applied with Holm correction for multiple comparisons.

Ethics and dissemination

The study has been submitted to the National Danish Research Ethics Committee and the Danish Data Protection Agency. As data derive from completed disease courses, no patient contact is expected. Results will be disseminated through peer-reviewed journals, conferences and scientific presentations.

Illness perception and self-management behaviours in adults with multimorbidity: a systematic review protocol

Por: Junger · A. L. · Fonseca · E. S. · Sousa · A. L. L. · Batista · S. R. R.
Introduction

Multimorbidity, characterised by the coexistence of two or more chronic conditions, represents a growing challenge for health systems, adversely affecting quality of life, self-care, treatment adherence and service utilisation. Within the context of self-regulation in health, the Common-Sense Model of Self-Regulation of Health and Illness (CSM) proposes that illness perceptions—such as beliefs about causes, control, consequences, timeline and illness identity—influence health behaviours. Despite consolidated evidence in single-disease contexts, little is known about how these perceptions operate when multiple conditions coexist, particularly due to the need to integrate potentially conflicting representations. To date, no systematic reviews have synthesised these relationships specifically in populations with multimorbidity. This protocol describes the methods for a systematic review aimed at examining how illness perceptions are associated with treatment adherence, self-care and indicators of chronic condition management in adults with multimorbidity.

Methods and analysis

This systematic review will be reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. Observational studies involving adults (≥18 years) with multimorbidity, which assess illness perceptions using validated instruments and report outcomes related to treatment adherence, self-care or self-management behaviours, will be included. The search will be conducted in the PubMed, Scopus, Web of Science, Embase, CINAHL, PsycINFO and LILACS databases, using combinations of descriptors related to illness perception, multimorbidity and health behaviours. Two independent reviewers will conduct study selection, data extraction and methodological quality assessment. The risk of bias will be assessed using the Newcastle-Ottawa Scale, and the overall quality of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Where appropriate, meta-analysis will be conducted using measures of association (eg, ORs, relative risk or HRs); otherwise, a structured narrative synthesis will be performed. Subgroup analyses will be conducted when data are available.

Ethics and dissemination

As it uses exclusively secondary and published data, this review does not require approval by a research ethics committee. The results will be submitted for publication in a peer-reviewed journal and disseminated at relevant scientific conferences.

PROSPERO number

CRD420251266292.

Scoping review of e-cigarette use in the perioperative setting: a protocol

Por: Harrogate · S. R. · Livingstone-Banks · J. · Hinchliffe · R. · Pope · I. · Mouton · R.
Introduction

E-cigarette use (often referred to as ‘vaping’) has increased rapidly over the past decade. Tobacco smoking is a well-established risk factor for adverse perioperative outcomes. While UK guidance supports e-cigarette use as a harm reduction and smoking cessation strategy, the perioperative implications of e-cigarette use are unclear. This scoping review aims to map the breadth and nature of the available evidence on e-cigarette use in the perioperative setting. It will describe how perioperative e-cigarette use is defined and measured, identify the perioperative populations and settings which have been studied, summarise reported perioperative outcomes and identify key knowledge gaps that should be addressed in future research.

Methods and analysis

This review will be conducted in accordance with Joanna Briggs Institute methodology and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines. MEDLINE, EMBASE, CINAHL, PsycINFO, Cochrane Central, Web of Science and grey literature sources will be systematically searched from 2003, when the first commercially available e-cigarette was introduced, to February 2026. Studies will be screened, and data extracted by two independent reviewers. Studies of any design examining perioperative e-cigarette use in the perioperative period, across all surgical specialities, will be included. Data will be synthesised narratively and presented using tabular and visual summaries. The study will be undertaken between 9 February and 1 August 2026.

Ethics and dissemination

Ethical approval is not required for scoping reviews. Findings will be disseminated by conference presentation and publication in a peer-reviewed open-access journal and communication with stakeholders.

Better outcomes for the older surgical patient trial (BOOST): protocol for a hybrid type 1 effectiveness-implementation trial of an embedded geriatric perioperative service within emergency and elective surgery in an Australian tertiary referral hospital

Por: Sagi · C. · Logan · H. · Epstein · E. · Holliday · E. · Smith · S. R. · Mackney · J. · Paul · C. L. · Clark-Pitrolo · S. · Gillies · D. · ONeill · C. J.
Introduction

Older patients admitted under surgical care have longer length of stay (LOS) and are at risk of functional decline, hospital-acquired complications and geriatric syndromes. Embedded specialist geriatrician models within surgical care teams can reduce length of stay and perioperative complications. Evidence gaps remain regarding the implementation of these models of care and their impact on patient outcomes. This study aims to measure hospital, patient and implementation outcomes of an embedded perioperative geriatric service in a large Australian tertiary referral hospital.

Methods and analysis

This hybrid type 1 effectiveness-implementation trial involves four services (emergency general, elective general, urology and vascular surgery), with a predicted reach of >2000 patients over 24 months. The intervention consists of a proactive geriatrician-led service providing a comprehensive geriatric assessment and ongoing review during the acute admission. Service evaluation will be via (1) traditional hospital outcomes (primary outcome LOS); (2) implementation outcomes; and (3) patient reported outcomes across three 6 month phases: (1) prior to service implementation; (2) during service implementation and (3) continued service but without active implementation. Data analysis will include descriptive statistics of patient demographics, clinical characteristics and implementation outcomes; cost-effectiveness; univariate and multivariate analysis of outcomes against demographic and clinical characteristics and thematic analysis of qualitative data.

Ethics and dissemination

This trial has been approved by the Hunter New England Research Ethics Committee (2024_ETH023259). The findings will be disseminated via peer-reviewed publications and conference presentations. The research team will facilitate adoption more broadly within the health service.

Trial registration number

Australian New Zealand Clinical Trials Registry (ACTRN12625000404426)

Methodologies and methods for the development, evaluation and implementation of psychosocial interventions for dementia: protocol for a scoping review

Por: DAndrea · F. · Bartels · S. L. · Markaryan · M. · Masterson-Algar · P. · Bernal · A. N. · De Bruin · S. R. · Chirico · I. · Flynn · A. · Garcia · L. · Gebhard · D. · Handley · M. · Janssen · N. · Roes · M. · Stephens · N. · Teesing · G. · Van den Block · L. · Windle · K. · Moniz-Cook · E.
Introduction

Research on psychosocial interventions for dementia demonstrates increased rigour and robustness. However, if we are to influence practice, beyond results from randomised controlled trials, a variety of types and sources of evidence is needed. The Medical Research Council (MRC) framework offers a valuable guide for developing, evaluating and implementing complex interventions, to facilitate integration of research into practice. There is limited knowledge of how researchers design, evaluate and implement psychosocial intervention studies in dementia, using the MRC framework. This scoping review aims to: (1) identify the methodological and methods trends, use and gaps in the development, evaluation and implementation of psychosocial interventions for dementia, and (2) determine if and how the MRC six core elements were considered and applied in studies.

Methods and analysis

Six databases (Ovid MEDLINE, Embase, PsycINFO, CINAHL, Web of Science, Cochrane Library) will be searched for studies published from 2015 (when MRC process guidance was published) to 2025. Identified deduplicated citations will be imported into Covidence software, where up to 40% of title/abstracts will be double screened by independent reviewers. ASReview will be used to rank articles by relevance, with a stopping criterion of 250 consecutive irrelevant articles. Full texts will be reviewed by a single reviewer and those excluded will be checked by a second reviewer. Data extraction will include study aim/objective (ie, to develop/adapt; test feasibility/pilot; evaluate; implement); methodology and methods applied; information on which MRC six core elements were considered (yes/no), and if so, how they were addressed (ie, qualitative details). A narrative synthesis, alongside graphical representations (eg, table/bar charts/histograms), will be used to synthesise findings on methodologies and methods mapped onto the MRC framework.

Ethics and dissemination

This secondary analysis scoping review does not require ethics approval. Results will be disseminated through peer-reviewed publication(s), seminars, webinars, conferences, postgraduate dementia programmes, blogs, commissioner briefings and social media. The findings will provide a state-of-the-art overview of current practices; advance methods/methodology such as informing a Delphi consensus study on appropriate research approaches; and guide researchers in application of the MRC framework to widen the scope of dementia care evidence for practice improvements.

Registration

Submitted to Open Science Framework https://doi.org/10.17605/OSF.IO/S56NQ.

Impact of a patient-centred levothyroxine decision support tool on rapid achievement of target dosage and improved patient outcomes: protocol for a randomised controlled trial

Por: Konst · S. R. · Hellemo · L. · Garcia · B. H. · Brun · V. H.
Introduction

The hormone replacement drug levothyroxine is the most common therapy for people with reduced function of the thyroid gland. The optimal dosage varies considerably between individuals, and reaching the correct dosage is often a time-consuming task. To reduce the time needed for dose adjustments, we have developed a model for calculating each patient’s optimal dosage and an associated decision support tool (DST). We present the study protocol for a randomised controlled trial using the DST in initiation and adjustment of levothyroxine therapy for thyroidectomised patients. The aim of the study is to assess the tool’s efficacy on therapeutic target achievement and to investigate whether faster dose adjustments lead to better patient-reported outcomes on symptoms and health-related quality of life (HRQoL).

Methods and analysis

We will conduct a randomised, controlled, multicentre, non-blinded, parallel arm trial with three intervention groups and one control group. We will include 240 patients undergoing total or completion thyroidectomy in three Norwegian hospitals. Patients allocated to the three intervention groups will have the option to use the DST in dose adjustments after the operation. Each intervention group will test a different version of the DST. The control group will follow standard care practice. The randomisation ratio will be 1:1:1:1. Our primary outcome is proportion of patients within biochemical target at 8 weeks postoperatively. Secondary outcomes are distance from biochemical target at 8 weeks, mean time to achieve biochemical target, change in HRQoL, adverse events and number of days absence from work.

Ethics and dissemination

The study has been approved by the Norwegian Medical Products Agency (CIV-23-02-042436), The Norwegian Ethics Committee for Clinical Trials on Medicinal Products and Medical Devices (547311), and the patient protection officer at the University Hospital of North Norway. All participants will give written informed consent prior to inclusion. Results will be published open access in international peer-reviewed journals and communicated to the public through appropriate channels.

Trial registration number

NCT06455371.

Analgesic efficacy of peri-operative methadone in orthopaedic surgery: protocol for a systematic review of randomised controlled trials

Por: Evaldsson · B. B. · Nygaard · K. H. · Petersen · S. R. · Moos · C. M. · Stroem · T. · Specht · K. · Schonnemann · J. O.
Introduction

Optimising post-operative pain management is crucial for recovery in orthopaedic surgery. Methadone has attracted interest due to its long half-life, N-methyl-D-aspartate -receptor antagonism and potential to reduce post-operative opioid consumption. Existing reviews combine multiple surgical populations, limiting applicability to orthopaedic settings. This protocol outlines a systematic review assessing the analgesic efficacy and safety of peri-operative methadone in adult and adolescent orthopaedic patients.

Methods and analysis

This review will include randomised controlled trials evaluating intravenous peri-operative methadone vs placebo or standard analgesic regimens in orthopaedic surgery. Primary outcomes are post-operative rescue opioid consumption and pain intensity within 72 hours. Secondary outcomes include adverse events, mobility scores and the length of hospital stay. If available data permit, a methadone dose–response pattern may be investigated. Searches will be conducted in MEDLINE (Ovid), Embase (Ovid), CINAHL, CENTRAL, Web of Science and ClinicalTrials.gov without date restrictions. Two reviewers will independently screen studies, extract data and assess risk of bias using the Cochrane risk-of-bias tool for randomised trials. When appropriate, random-effects meta-analysis methods will be performed. Certainty of evidence will be assessed using Grading of recommendations assesment, development and Evaluation (GRADE).

Ethics and dissemination

As this study uses previously published data, ethical approval is not required. Findings will be disseminated through a peer-reviewed publication and conference presentations.

PROSPERO registration number

CRD42025616291.

Postgraduate digital health training programmes for primary care physicians: a scoping review protocol

Por: Leon-Herrera · S. · Anjos De Almeida · V. · Yokus · S. E. · Li · E. · Batista · S. R. R. · Teixeira · J. · Neves · A. L. · Gomez Bravo · R.
Introduction

The digital transformation of healthcare has created an urgent need for primary care physicians (PCPs) to acquire competencies in digital health. However, the structure and scope of postgraduate training programmes remain poorly defined and unevenly implemented worldwide, and no scoping review has yet synthesised the evidence. This review aims to map existing postgraduate digital health training programmes for PCPs, including their content, structure and delivery approaches.

Methods and analysis

This scoping review will follow the Joanna Briggs Institute methodology and adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. A systematic search will be conducted across five databases (PubMed, Scopus, Cochrane Library, ScienceDirect and Web of Science) and relevant grey literature, covering publications from January 2019 to June 2025. Studies describing postgraduate digital health training programmes for PCPs will be eligible for inclusion. Data will be extracted and synthesised descriptively and thematically using an inductive approach.

Ethics and dissemination

As this study is based on a review of publicly available literature, ethical approval is not required. The findings will be disseminated through a peer-reviewed publication and conference presentations and will inform future curriculum development and policy in digital health education for PCPs. The results may also inform national curriculum reforms and accreditation standards, supporting more consistent and competency-based digital health education globally.

PROSPERO registration details

This scoping review protocol has been registered with the Open Science Framework.

Understanding recruitment to a randomised controlled trial (RCT) during liver transplantation: an observational mixed-methods Study Within A Trial (SWAT)

Por: Coppack · K. E. S. · Kantsedikas · I. · Brodkin · E. · Loh · E. N. · Ambler · G. · Moonesinghe · S. R. · Fabes · J. · Hannon · V. · Spiro · M. · Wagstaff · D.
Objectives

Perioperative randomised controlled trials (RCTs) in liver transplantation are relatively infrequent. RCTs performed in this complex patient population need to be robustly conducted to maximise patient benefit and graft utility given the scarcity of donor organs. Recruitment challenges can compromise RCTs and studies in this population face unique challenges due to recipient illness severity, their comorbidities, demographics and the geographical constraints of specialist transplant centres. Emergency presentation and after-hours admission may further limit patients’ capacity or readiness to consider trial participation. This Study Within a Trial (SWAT) specifically explored motivators and barriers to recruitment in patients awaiting liver transplantation.

Design

An observational mixed-methods ‘Study within a Trial’, nested within a feasibility RCT.

Setting

This study was dual centred at two Tertiary National Health Service Hospitals; The Royal Free Hospital, a liver transplant centre in North London and University Hospital Birmingham, a liver transplant centre in Birmingham.

Participants

Adults who were eligible for liver transplantation and recruitment into the associated RCT were eligible for inclusion into the SWAT.

Interventions

Completion of an 18-question validated written questionnaire which explored motivation for accepting or declining participation in the RCT.

Main outcome measures

Through completion of the questionnaire, participants shared their perspectives on the RCT and their rationale for consenting or declining participation. Responses were analysed, providing feedback to the Trial Management Group (TMG) to refine recruitment strategies for future trials. An additional component, comprising interviews and audio recordings of recruitment consultations, was planned if the RCT recruitment rates fell below prespecified thresholds or concerns were raised by the RCT TMG, neither of which occurred.

Results

84 completed questionnaires were received. Motivators included patients believing that the trial will benefit others, interest in helping with research, perception that benefits outweigh risks and belief that it offered the best treatment. Barriers included concerns about randomisation, feeling overburdened and a perception of lack of support from family or friends.

Conclusion

This is the first study exploring recruitment to a perioperative RCT involving patients undergoing liver transplantation. Key motivators were altruism and perceived safety, while barriers included concerns about randomisation and lack of family support. Future focus during recruitment should be on neutral patient-centred consultations, adequate information sharing, fostering of patient trust, improved explanation of randomisation and engagement of the patient’s support network.

Trial registration number

NCT04941911 (Health Research Authority) and SWAT 152 (the Study With A Trial Database).

Physician beliefs regarding venous thromboembolism prophylaxis at a large multihospital US healthcare system: a cross-sectional survey study

Por: Moss · S. R. · Bhattacharyya · O. · Mittman · B. G. · Gunaratne · T. · Campoamor · N. B. · Bridges · J. F. · Rothberg · M. B.
Background

Venous thromboembolism (VTE) contributes to hospitalisation-associated morbidity. Although guidelines recommend limiting VTE prophylaxis to high-risk patients, some physicians prescribe it broadly. We compared beliefs of low and high prescribing physicians.

Methods

We surveyed hospitalists and medical residents who had the opportunity to prescribe prophylaxis ≥50 times. Best-worst scaling was used to assess their beliefs. Using a balanced incomplete block design, we created seven choice tasks with seven statements regarding prophylaxis beliefs each presented four times. For each task, physicians selected the statement that most and least reflected their beliefs. We used a count method to calculate best-worst scores and a conditional logistic regression choice model to compare low and high prescribers.

Results

Of 434 invitees, 172 (40%) completed all survey questions between June and November 2023. Low (n=86, ≤62.5% prescribing rate) and high (n=86, >62.5 prescribing rate) prescribers endorsed similar beliefs with differing levels of agreement. All felt confident to prescribe prophylaxis appropriately (low: +1.13, high: +1.10, p=0.81). High prescribers expressed more concern about VTE without prophylaxis (+1.02 vs +0.65, p=0.002). Low prescribers disagreed more that prophylaxis had no downside (–1.03 vs –0.73, p=0.01). High prescribers worried less about prophylaxis risks (–0.49 vs –0.22, p=0.01), and overuse (–0.61 vs –0.34, p=0.02).

Conclusions

Compared with low prescribers, high prescribers were more concerned about VTE without prophylaxis and less about harms. These differences in beliefs may underlie physician behaviour and could be targets for interventions to reduce inappropriate prophylaxis.

Pittsburgh Brain Health Initiative (BHI): protocol and methods for an observational study of cognitive function in former professional football players and controls

Por: Okonkwo · D. O. · Collins · M. W. · Kontos · A. P. · Lopez · O. · Mountz · J. M. · Wisniewski · S. R. · Edelman · K. L. · Benso · S. · Holland · C. · Beers · S. R. · Soose · R. J. · Harrison · T. · Mucha · A. · Puccio · A. · Mancinelli · M. · Borrasso · A. · Rosario · B. L. · Laymon · C.
Introduction

Long-term brain health profiles following exposure to repetitive head impacts and/or concussions in contact sports are a public health focus and the subject of a national debate. The true prevalence rates of mild cognitive impairment (MCI) or neurobehavioural dysregulation are unknown in the nearly 20 000 current/living former professional football players. Here, we describe the procedures and methodology of the prevalence study of cognitive function in former professional football players from the Brain Health Initiative at the University of Pittsburgh. The objective is to define the prevalence of normal cognitive function versus neurodegeneration in former professional football players through clinical, neuroimaging and biomarker assessments.

Methods and analysis

Participants include former professional football players aged 29–59 years at study onset who played a minimum of three professional football games in three professional seasons and non-exposed controls. Participants are recruited by two mechanisms, a random and non-random sample. The full study protocol includes a 3–4-day, multidomain assessment (eg, neurological, neurocognitive, psychiatric, sleep, vestibular, orthopaedic and cardiovascular) for neurodegenerative disease and overall health and function, including MRI, positron emission tomography scans, analysis of blood plasma and cerebrospinal fluid, neurocognitive assessments, applanation tonometry, overnight sleep study and informant interview. A multidisciplinary clinical panel conducts a blinded diagnostic consensus conference to adjudicate the presence of MCI and/or traumatic encephalopathy syndrome, which serve as the study’s primary and secondary outcomes, respectively. Point prevalence of these for both the exposed and unexposed cohorts will be calculated as the primary statistical analysis.

Ethics and dissemination

The University of Pittsburgh Institutional Review Board approved the study prior to recruiting human subjects (protocol numbers STUDY19010008: sIRB - Brain Health Initiative (Part 1) and STUDY19030211: sIRB - Brain Health Initiative (Part 2)). The results will be disseminated in peer-reviewed journals and as presentations at national and international scientific conferences.

Prospective randomised controlled trial of the use of nasogastric tubes in patients with adhesive small bowel obstruction (ASBO): protocol for the NASBO study

Por: Al-Mashat · A. · Smith · S. R. · Gani · J. · ONeill · C. J. · Burnett · D. · Carroll · R. · Lott · N.
Introduction

Nasogastric tubes (NGTs) are standard practice in the management of adhesive small bowel obstruction (ASBO). Their insertion can be associated with significant patient discomfort and complications. Current research suggests that patients with ASBO managed with NGTs may experience poorer outcomes and higher rates of operative intervention compared with those managed without. However, to date, there are no prospective clinical trials evaluating this.

Methods and analysis

This study will be designed as a single centre, prospective, non-inferiority randomised controlled trial to determine if the avoidance of an NGT is non-inferior to its use in ASBO. Patients meeting inclusion criteria will be randomised to either receive an NGT or no NGT for ASBO management. The primary outcome will be the rate of operative intervention as determined by review of medical records at day 30 post discharge. Secondary outcomes will include rate of bowel resection or bowel ischaemia, length of hospital and intensive care unit (ICU) stay, time to operative intervention, rate of ICU admission, incidence of postoperative complications (Clavien-Dindo classification), quality of life scores (European Quality of Life 5 Dimension 5 Level: EQ-5D-5L) at admission, day 30 and day 90, 90-day mortality, incidence of pulmonary complications (Melbourne Group Scale), rate of NGT specific complications and rate of Gastrografin use. The study will be powered at 80% to detect a clinically relevant difference of 10% between groups receiving an NGT compared with no NGT, requiring a total of 490 study participants. Statistical analysis will follow intention to treat principles. Differences between treatment arms will be summarised using mean differences, 95% CIs and p values.

Ethics and dissemination

This study has been approved by the Hunter New England Human Research Ethics Committee (2023/ETH00296). Results will be disseminated through peer-reviewed publication and conference presentations.

Trial registration number

This study has been registered prospectively in the Australia and New Zealand Clinical Trials Registry (ACTRN12623000341628).

Sociodemographic and geographical variation in prescribing psychotropic drugs to children and young people with common mental disorders and Attention Deficit Hyperactive Disorders in North West London: population-based study

Por: Lazzarino · A. I. · Naulls · S. R. · Bakhti · R. · Hope · S. · Nicholls · D. · Otis · M. · Robinson · T. · Gnani · S. · Hargreaves · D. S.
Objectives

To estimate the sociodemographic and geographical variation in prescribing selective serotonin reuptake inhibitors (SSRIs) and medications for attention-deficit/hyperactivity disorder (ADHD) to children and young people (CYP) in North West London, UK.

Design

Cross-sectional population-based study.

Setting

General practices in North West London, UK, with data for the period 2020–2022 obtained from the Discover Now platform, which covers approximately 95% of the local population.

Participants

762 390 CYP aged 5–24 years in the year 2022.

Primary and secondary outcome measures

Primary outcome: Prescription rates of SSRIs and ADHD medications. Secondary outcomes: Associations between prescription rates and sociodemographic factors, including age, gender, geographical area (local authority), ethnicity and socioeconomic deprivation (measured using the Index of Multiple Deprivation).

Results

The total sample comprised 762 390 CYP. 2.20% of the sample were prescribed an SSRI (95% CI 2.17% to 2.24%) and 0.50% an ADHD medication (95% CI 0.49% to 0.52%) in years 2020–2022. High deprivation was associated with the highest rates of an SSRI prescription (2.5%). In contrast, low deprivation was associated with the highest rates of an ADHD medication prescription (0.70%). This divergent pattern was evident in some London boroughs and not in others. The relationship between level of area deprivation and prescription rates also differed by borough. Overall, the sociodemographic factors could not explain most of the variation in prescription rates (Pseudo R2 0.18 for SSRI and 0.06 for an ADHD medication).

Conclusions

Prescriptions for common mental disorders and ADHD for CYP from North West London varied by sociodemographic characteristics and London borough of residence, potentially exacerbating mental health inequalities. To monitor and address these inequalities, more extensive use of linked electronic health records should be undertaken; for example, data on mental health diagnosis and service utilisation are needed to investigate the relationship between diagnosis and treatment over time.

Public health assistance for people with haemophilia in Brazil (PATCH study): a cross-sectional study protocol

Por: Roberti · M. d. R. F. · Gea · Y. R. e. A. · Marinho · I. A. · Inacio · P. P. · Camelo · R. M. · de Castro · T. F. · Batista · S. R. R.
Introduction

Haemophilia is a rare inherited bleeding disorder with complex support and costly treatment. Comprehensive care for people with haemophilia (PwH) must take place in structured and continuously evaluated treatment centres. The aim of the Public Assistance for People with Haemophilia in Brazil Project (PATCH Project) is to assess the infrastructure, human resources and healthcare delivery processes of Brazilian Blood Centres (BC) involved in the provision of haemophilia care.

Methods and analysis

This is a nationwide cross-sectional study involving 98 BC across Brazil’s 26 states and the Federal District, focusing on the care provided to PwH. A self-administered structured questionnaire was prepared, based on national and international recommendations for management, treatment and outcomes assessment in PwH. The criteria of the World Federation of Haemophilia and the European Association for Haemophilia and Allied Disorders will be used to define standards of quality.

Ethics and dissemination

Ethical approval for this study was granted by the Human Research Ethics Committee of the Federal University of Goiás, the coordinating centre (protocol CAAE 53863221.8.0000.5078), and subsequently by all participating institutions. Written informed consent is obtained from all participants prior to enrolment. Study findings will be disseminated through publication in peer-reviewed journals and presentation at international scientific conferences. Research data will be managed in accordance with ethical and legal standards and will be made available on reasonable request to support future investigations.

Protocol registration

Not applicable

Factors associated with unacceptable knowledge, attitudes and practices of patients with type 2 diabetes on cardiovascular risk factors and diabetes-related complications in two health facilities of the West Region of Cameroon during the COVID-19 pandemic

Objective

To assess the level of knowledge, attitudes and practices (KAP) among patients with type 2 diabetes mellitus (T2DM) regarding cardiovascular risk factors (CVRF) and diabetes-related complications in two hospitals in the West Region of Cameroon during the COVID-19 pandemic.

Design

This was a prospective cross-sectional study conducted over 5 months from April to September 2022.

Setting

This study was conducted in two tertiary hospitals in the West Region of Cameroon, in Central Africa.

Participants

It included all patients with T2DM receiving care at these two hospitals, having agreed to participate and followed up in both hospitals for at least 3 months.

Primary and secondary outcome measures

Sociodemographic, clinical and treatment data were collected using a data sheet, and KAP scores were based on the Essi and Njoya framework. Data collection and analysis were performed using SPSS V.23.0 software. Logistic regression was used to identify the factors associated with unacceptable KAP (p

Results

A total of 140 participants (71 women) with an average age of 63 years and an average diabetes duration of 6.14±5.7 years were included. Most (55%) were managed by general practitioners. The main CVRFs identified were hypertension (11%) and overweight (6%), while the leading complications included visual disorders (10.7%), hypoglycaemia (6.4%) and erectile dysfunction (2.1%). Knowledge was good in 34.3% of participants, only 25.7% demonstrated correct attitudes, and merely 15.7% engaged in adequate practices. Unacceptable knowledge was associated with diabetes duration between 3 months and 5 years (OR: 0.34 (95% CI 0.14 to 0.85), p=0.021), follow-up by a specialist (OR: 0.31 (95% CI 0.13 to 0.74), p=0.009), the presence of at least one CVRF (OR: 0.03 (95% CI 0.00 to 0.23), p

Conclusion

Few people with T2DM presented good knowledge, right attitudes and adequate practices. Enhanced patient education and increasing specialist numbers are essential to promote self-management of the condition and to decrease the incidence of complications and mortality.

Individualised dosimetry for holmium-166 RE in patients with unresectable hepatocellular carcinoma; a multi-centre, interventional, non-randomised, non-comparative, open label, phase II study: RHEPaiR

Por: Qurashi · M. · Martinez · M. · Ward · C. · Wyard · C. · Izadi · H. · Bowen · C. · Khan · S. R. · Tait · P. · Smits · M. · de Bruijne · J. · Thomas · R. · Lam · M. G. E. H. · Sharma · R.
Introduction

Radioembolisation (RE) is gaining traction as a robust treatment option for patients with hepatocellular cancer (HCC) across all cancer stages. RE allows the delivery of targeted high-dose radiation directly to tumours, with relative sparing of the surrounding liver tissue. Traditionally, radiation has been delivered using 90Yttrium ([90Y]Y)-labelled microspheres, either glass or resin. The success of RE is dependent on the dose delivered to the tumour. When using [90Y]Y microspheres, dose prediction is calculated through a 99mTechnitium ([99mTc]Tc)-macroaggregated albumin (MAA) scan, which allows the calculation of the dose to be administered to the tumour. However, [99mTc]Tc-MAA is not a true surrogate of [90Y]Y microspheres, and this will impact on the final dose delivered. [166Ho]Ho, like [90Y]Y, is a beta emitter but unlike [90Y]Y also emits gamma-radiation, allowing for quantitative nuclear imaging. The primary aim of this pilot study was to investigate the safety and efficacy of dosimetry-based individualised 166Holmium ([166Ho]Ho-RE) in patients with HCC.

Methods and analysis

15 eligible participants will be recruited to receive [166Ho]Ho-RE. The primary objective is to establish the toxicity profile of dosimetry-based individualised [166Ho]Ho-RE. The secondary objective is to assess efficacy as measured by modified Response Evaluation Criteria in Solid Tumours (mRECIST) and Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria. Additional exploratory objectives include quality of life assessment and identification of a radiomic signature of response. The results from this study will be combined with the prospective iHEPAR study to form a larger analysis.

Ethics and dissemination

The study has received approval from the East Midlands—Nottingham 1 Research Ethics Committee—approval number 23/EM/0239. The study will be performed in compliance with the Declaration of Helsinki and the principles of Good Clinical Practice. Signed informed consent will be obtained from each patient before study entry. The results will be disseminated through publication in a peer-reviewed scientific journal.

Trial registration number

Clinicaltrials.gov NCT06302400.

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