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Hoy — Diciembre 16th 2025Tus fuentes RSS

Efficacy and safety of microbiota-targeted therapeutics in autoimmune and inflammatory rheumatic diseases: protocol for a systematic review and meta-analysis of randomised controlled trials

Por: Kragsnaes · M. S. · Gilbert · B. T. P. · Sofiudottir · B. K. · Rooney · C. M. · Hansen · S. M.-B. · Mauro · D. · Mullish · B. H. · Bergot · A.-S. · Mankia · K. S. · Goel · N. · Bakland · G. · Johnsen · P. H. · Miguens Blanco · J. · Li · S. · Dumas · E. · Lage-Hansen · P. R. · Wagenaar
Introduction

An abnormal composition of gut bacteria along with alterations in microbial metabolites and reduced gut barrier integrity has been associated with the pathogenesis of chronic autoimmune and inflammatory rheumatic diseases (AIRDs). The aim of the systematic review, for which this protocol is presented, is to evaluate the clinical benefits and potential harms of therapies targeting the intestinal microbiota and/or gut barrier function in AIRDs to inform clinical practice and future research.

Methods and analysis

This protocol used the reporting guidelines from the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol. We will search Embase (Ovid), Medline (Ovid) and the Cochrane Library (Central) for reports of randomised controlled trials of patients diagnosed with an AIRD. Eligible interventions are therapies targeting the intestinal microbiota and/or gut barrier function including probiotics, synbiotics, faecal microbiota transplantation, live biotherapeutic products and antibiotics with the intent to modify disease activity in AIRDs. The primary outcome of the evidence synthesis will be based on the primary endpoint of each trial. Secondary efficacy outcomes will be evaluated and selected from the existing core domain sets of the individual diseases and include the following domains: disease control, patient global assessment, physician global assessment, health-related quality of life, fatigue, pain and inflammation. Harms will include the total number of withdrawals, withdrawals due to adverse events, number of patients with serious adverse events, disease flares and deaths. A meta-analysis will be performed for each outcome domain separately. Depending on the type of outcome, the quantitative synthesis will encompass both ORs and standardised mean differences with corresponding 95% CIs.

Ethics and dissemination

No ethics approval will be needed for this systematic review. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to disseminate the study results through a peer-reviewed publication.

PROSPERO registration number

CRD42025644244.

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

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

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

NCT06965738.

Sources and consequences of self-doubt in patients with Ehlers-Danlos syndrome: a qualitative study in Europe and North America

Por: Halverson · C. M. E. · Vershaw · S. L. · Francomano · C. A. · Doyle · T.
Objectives

To examine how clinicians’ scepticism regarding patients’ self-reports of subjective symptoms can be internalised, leading to psychosocial and medical harms.

Design

In-depth, semi-structured qualitative interviews with the resulting data analysed using reflexive thematic analysis.

Participants

43 individuals with Ehlers-Danlos syndrome (EDS) from Europe and North America completed a pre-survey, and 39 of those participants completed interviews for this study. Purposive sampling was used to obtain approximately equal numbers of participants with hypermobile EDS and the molecularly defined types of EDS.

Results

Patients with both hypermobile and molecularly defined types of EDS reported high levels of self-doubt, with 73% of survey respondents questioning the extent—and even reality—of their private experiences of pain. Participants attributed much of their self-doubt to repeated dismissal and minimisation of their symptoms in healthcare settings, especially during childhood. Ultimately, self-doubt transformed not merely how they communicated their symptoms but also how they recognised, evaluated and even experienced them at a phenomenological level. While some participants developed coping strategies, others withdrew from the conventional medical system altogether.

Conclusion

These findings have important implications for clinicians, who may inadvertently reinforce self-doubt through discussion of diagnostic uncertainty. Doubt need not be delegitamising. Recognising and mitigating these potential harms requires epistemic humility and attention to the psychosocial dynamics of patient-provider interaction.

Surgical and oncological outcomes of right hemicolectomy with complete mesocolic excision in the treatment of right colon cancer: study protocol for a single-centre retrospective cohort study

Por: Nava · C. M. · Najberg · H. · Adamina · M. · Litchinko · A.
Introduction

Complete mesocolic excision (CME) with central vascular ligation (CVL) has been proposed as an oncologically superior surgical technique for right-sided colon cancer, mirroring the impact of total mesorectal excision (TME) in rectal cancer. While promising results have been reported, evidence from routine clinical practice, particularly within Swiss healthcare settings, remains limited. This study aims to evaluate the surgical and oncological outcomes of CME compared with standard right hemicolectomy (non-CME) over a 10-year period.

Methods and analysis

This is a retrospective cohort study of adult patients who underwent right hemicolectomy, either CME or non-CME, for histologically confirmed adenocarcinoma of the right colon or right third of the transverse colon at a tertiary centre, between 2010 and 2020. Patients with concomitant malignancies or distant metastases will be excluded. The primary outcome is 3-year and 5-year disease-free survival. Secondary outcomes include number of harvested lymph nodes, 3-year and 5-year overall survival, and 30-day morbidity.

Ethics and dissemination

This study was approved by the relevant Ethics Committee (CER-VD 2025-00503). All patients provided general consent for secondary use of anonymised data. Results will be submitted to a peer-reviewed journal and presented at national and international conferences.

Assessments, diagnostic criteria and outcome measures for growing pains and persistent pain in the presence of restless leg syndrome in children: a scoping review

Por: Smith · M. · Pacey · V. · Davies · L. M. · Coventry · J. · Ilhan · E. · Williams · C. M.
Objective

To identify the assessments, diagnostic criteria and outcome measures reported in peer-reviewed literature for children with growing pains and persistent lower limb pain in the presence of restless leg syndrome (RLS).

Study design

Scoping review completed in line with Joanna Briggs Institute methodological guidance

Data sources

Five online databases were searched—MEDLINE, Embase, CINAHL, PsycINFO and AMED—for records up to 14 October 2024.

Eligibility criteria

Records reporting on the use of assessments, diagnostic criteria or outcome measures in children (aged 0–18 years) with growing pains or persistent lower limb pain in the presence of RLS. Articles were required to have a sample size of ≥10 and be available in English language.

Data extraction and synthesis

Data were extracted by two independent reviewers and analysed using descriptive statistics.

Results

Following review of 19 806 records, 61 unique records were included. Most were observational cross-sectional or case–control designs. Assessments were varied and primarily focused on body functions and pain characteristics rather than activities and participation. There were 15 unique diagnostic criteria reported for growing pains with limited consistency and sometimes conflict between included items. Outcomes measures were only reported in eight records and typically measured pain presence and intensity.

Conclusions

Assessment and subsequent diagnosis of growing pains and persistent pain in the presence of RLS lack consistency. Outcome measures were seldom used as most records were not designed to measure change over time. Standardised practices for assessment and management of these conditions may benefit clinicians and optimise patient care.

Is Cardiovascular Mortality Among People with Epilepsy increasing? A retrospective US population study

Por: Curtis · A. · Markovic · D. · Liao · A. · Ganapa · S. · Gaertner · M. · DeGiorgio · C. M.
Introduction

People with epilepsy are at higher risk for hypertension, diabetes, hyperlipidaemia and obesity than the US general population. It is unknown whether these risk factors translate to increased cardiovascular mortality compared with the US general population.

Objective

To examine changes in the proportions of deaths due to cardiovascular causes among people with epilepsy in the USA.

Hypothesis

Cardiovascular mortality among people with epilepsy is rising in the USA compared with the general population over the period from 2000 to 2019.

Design/methods

Retrospective, longitudinal US population study of all deaths among people with epilepsy due to cardiovascular causes compared with the US general population for the years 2000 through 2019. Source data were obtained from the Centers for Disease Control and Prevention (CDC) Multiple Cause of Death Database using all International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) codes for epilepsy (specifically all ICD-10 codes G40.0 through G40.919). The use of administrative datasets, like the CDC Multiple Cause Of Death Database, is a validated method that effectively captures US epilepsy mortality when using the ICD-10 codes G40.0–G40.9. Cardiovascular deaths were operationally defined as ischaemic heart disease, cerebrovascular disease, diabetes and hypertension. Data were stratified by age, race and gender. Relative proportions of each cause of death were expressed as a percentage of total deaths and evaluated on the log-odds scale using a logistic regression model. Standardised proportions were also used and reported.

Primary and secondary outcomes

Within-group and between-group differences in the rate/proportions of deaths due to cerebrovascular disease, ischaemic heart disease, diabetes and hypertension among people with epilepsy and the general population over a 20-year period.

Setting

US epilepsy and general populations.

Results

Age-adjusted mortality for cerebrovascular disease and diabetes increased significantly among people with epilepsy compared with the US general population over the 20-year period (p

Conclusions

Age-standardised proportions of deaths attributed to cerebrovascular disease and diabetes increased significantly among people with epilepsy from 2000 to 2019. Age-stratified proportions of deaths due to cerebrovascular disease and diabetes occurred primarily in the 35–64-year age range. The long decline in the proportions of deaths due to ischaemic heart disease among people with epilepsy ended after 2011, despite continuing to decline in the general population. The increase in proportions of cardiovascular deaths among people with epilepsy is likely due to higher cardiovascular risk factors compared with the general US population. Increased surveillance and treatment of cardiovascular risk factors among people with epilepsy are indicated, especially in the critical 35–64-year age group, where improved primary prevention may reduce cardiovascular risk and mortality.

Little ears - Aboriginal programmes for hearing and EAR screening (LEAP - HEAR): a research protocol for co-design workshops to strengthen programmes

Por: Mealings · K. · Halvorsen · L. · Nash · K. · MacQueen · D. · Ward · K. · McMahon · C. M.
Introduction

Multiple well-considered but siloed initiatives and programmes exist in Australia to support ear and hearing screening and assessment for Indigenous children. However, the lack of coordination of these programmes leads to inefficiencies in resource allocation and disrupts opportunities to implement a cost-effective, efficient, and easily navigable system of care. Indigenous children experience high prevalence rates of middle ear disease, as well as earlier onset, increased severity and longer infections compared with non-Indigenous children. The aims of this study are to: (1) Understand current ear and hearing screening programmes in three New South Wales communities and evaluate their strengths and limitations, (2) Strengthen, implement and evaluate ear and hearing screening programmes and (3) Identify the barriers and facilitators for scaling strengthened ear and hearing screening programmes nationally and the importance and feasibility of each factor.

Methods and analysis

A series of desktop searches and co-design workshops will be completed to achieve aim (1) and (2) and the results will be mapped into work-as-done and work-as-imagined using the Functional Resonance Analysis Method. Strengthened screening programmes will be implemented in communities using the criteria from national and international guidance documents and the Practical, Robust, Implementation and Sustainability Model and evaluated. Finally, workshops will be conducted with key stakeholders to identify the barriers and facilitators for scaling strengthened ear and hearing screening programmes nationally and the importance and feasibility of each factor.

Ethics and dissemination

This project has received ethics approval from the Aboriginal Health and Medical Research Council Human Research Ethics Committee (Ref: 2350/24). Results will be disseminated to the community through the CEOs of the Aboriginal Community Controlled Health Organisations as well as published in peer-reviewed journals and presented at conferences. The findings from data collected will be used to inform the co-production of an enhanced system for ear and hearing care.

Genitourinary syndrome of menopause induced by breast cancer treatments: a randomised clinical trial protocol comparing multimodal pelvic floor physiotherapy and fractional CO2 laser therapy (PILME study)

Introduction

Genitourinary syndrome of menopause (GSM) is a prevalent condition among breast cancer survivors, often exacerbated by oncological treatments. Hormonal therapies are typically contraindicated in this population, necessitating effective non-hormonal interventions.

Methods and analysis

This randomised controlled trial aims to compare the effectiveness and cost-effectiveness of multimodal pelvic floor physiotherapy—comprising pelvic floor muscle training, non-ablative radiofrequency, therapeutic pelvic health education and the use of vaginal moisturisers—versus fractional CO2 laser therapy combined with vaginal moisturisers in alleviating GSM symptoms in breast cancer survivors. Participants will be randomly assigned to one of the two intervention groups. Primary outcomes include measures of sexual function (assessed by the Female Sexual Function Index), subjective pelvic perineal pain intensity (measured with a 100 mm Visual Analogue Scale) and health-related quality of life (assessed by the Functional Assessment of Cancer Therapy-Breast), assessed at baseline, post-intervention and at 3, 6 and 12 months of follow-up. Statistical analyses will be conducted to evaluate the clinical efficacy and cost-effectiveness of the interventions.

Ethics and dissemination

The study protocol has been approved by the Ethics and Health Research Committee of the University of Alcalá (Reference: CEIP/2024/1/012). All participants will provide informed consent prior to inclusion in the study. Findings will be disseminated through peer-reviewed journals and conference presentations, and by engaging with patient associations and survivor groups through tailored materials.

Trial registration number

NCT06721936.

Adherence to Choosing Wisely Africa recommendations in breast cancer care: a cross-sectional study across three Sub-Saharan African centres

Por: Rubagumya · F. · Rugengamanzi · E. · Nyagabona · S. K. · Ndumbalo · J. · Kwizera · V. · Uwimbabazi · A. · Celyna · K. · Ayettey · H. · Vanderpuye · V. · Hopman · W. M. · Hammad · N. · Booth · C. M.
Objective

The expenses associated with cancer treatment are increasing at a rapid pace. The financial strain of providing care is experienced worldwide, but is particularly pronounced in low and middle-income countries (LMICs). This has resulted in a growing acknowledgement of the importance of value-based cancer care. Choosing Wisely Africa (CWA) is an initiative aimed at reducing the excessive use and expenses associated with cancer treatment. In this study, we assessed adherence to CWA recommendations for the treatment of breast cancer in three high-volume cancer centres in Sub-Saharan Africa (SSA).

Design

A cross-sectional study across Rwanda, Ghana and Tanzania was conducted, involving a review of medical records to assess adherence to five measurable CWA practices in breast cancer care. The study used inferential statistics, such as 2 tests, to compare adherence among these countries.

Settings

This study was conducted in three cancer centres (Ocean Road Cancer Institute, Rwanda Military Hospital and Korle Bu Teaching Hospital) in three countries (Tanzania, Rwanda and Ghana, respectively).

Participants

A total of 542 patients were recruited. Eligible patients were those with a breast cancer diagnosis and complete data as pertaining to five CWA recommendations.

Results

A total of 542 participants with a mean age of 51 years were included. Participants were well distributed across Ghana (37%), Rwanda (34%) and Tanzania (29%). Female patients represented 97% of the study cohort. Half (51%) of the participants had some form of insurance. The study observed high adherence to cancer staging (94%) before treatment and histological confirmation (91%) before breast lump removal across all sites. Hypofractionation was used in 0% of cases in Rwanda, 42% in Ghana and 70% in Tanzania.

Conclusion

This study provides critical insights into the implementation of CWA recommendations in breast cancer care in SSA. It highlights the disparities in adherence to CWA recommendations across different centres, showing the need for policy-driven changes and healthcare infrastructure improvement to standardise cancer care practices in LMICs.

Gender gaps in healthy life expectancy as indicators of inequality for disability and chronic disease: cross-sectional evidence from 24 countries, years 2014-2019

Por: Di Lego · V. · Nepomuceno · M. R. · Turra · C. M.
Objective

Gender gaps in healthy life expectancy are frequently used as indicators of health inequality between women and men. However, total gaps can be misleading—masking critical disparities such as women living longer yet spending more years with disability or illness, or men experiencing premature mortality. We therefore critically evaluate whether these gaps accurately capture gender-based health.

Design

We estimate gender gaps in disability- and chronic disease-free life expectancy using the Sullivan method and decompose those gaps via the continuous-change approach to distinguish mortality from morbidity contributions. Data are drawn from the harmonised Gateway to Global Aging Data and the UN life tables from the 2022 Revision of World Population Prospects for all countries, except England, where the life tables are from the UK Office for National Statistics.

Setting

The analysis is performed on 24 countries and regions, including the USA, England, South Korea, China, India, Mexico and 19 European Union countries for the years 2014–2015 and 2017–2019 (N=201 723).

Main outcome measures

The main outcomes are gender gaps in disability- and chronic disease-free life expectancy and the contribution of mortality and health in explaining the gender gap.

Results

Gender gaps in disability-free life expectancy ranged from –0.37 years (Portugal) to almost 5 years (South Korea), with most European countries showing female advantages of 3.0–3.5 years, while minimal gaps were observed in China, Mexico and India (0.4–0.9 years). Decomposition revealed striking inconsistencies between total gaps and underlying components—South Korea’s 4.9-year gap reflected a survival advantage outweighing disability disadvantage by 13-fold, while Portugal’s –0.37-year gap masked opposing contributions (mortality: +2.3; disability: –2.7). Chronic disease-free life expectancy showed female disadvantage in most countries, especially Portugal (–2.3), Korea (–1.6) and Mexico (–1.9).

Conclusions

Using gender gaps in healthy life expectancy as a metric for gender inequality in health is misleading. Countries with very different levels of development, healthcare systems and gender roles can have similar gender gaps, but substantial differences in the levels of mortality and health. Because these gaps mask important underlying differences in health and mortality between women and men, caution is warranted when using them.

Implementability of a co-designed programme to increase tailored exercise to reduce falls in older people from culturally and linguistically diverse communities: protocol for a pilot randomised controlled trial

Por: Said · C. M. · Ramage · E. R. · Sharma · H. · Batchelor · F. · Bicknell · E. · Bongiovanni · L. · Brijnath · B. · Cahill · P. · Callisaya · M. · Celestino · S. · Chudecka · A. · Engel · L. · Lim · W. K. · McDonald · C. E. · Pinheiro · M. · Sherrington · C. · Vogrin · S. · Zanker · J. · Zhe
Introduction

Falls are a critical problem for older people, including those from ethnically diverse communities, who are under-represented in research. The aim of this pilot trial is to evaluate (1) the implementability of a co-designed intervention developed to support the sustained uptake of tailored exercise to reduce falls (MOVE Together: Reduce Falls) and (2) the feasibility of conducting a randomised controlled trial (RCT) in older people from Italian, Arabic, Cantonese or Mandarin-speaking communities.

Methods and analysis

Investigator and assessor-blinded pilot two-arm parallel RCT. 60 older people at risk of falls from Italian, Arabic, Cantonese or Mandarin speaking communities will be recruited, with the option to enrol on their own or with another participant (dyad). Participants or dyads will be randomly assigned to the experimental or control arm. The experimental arm will receive MOVE Together: Reduce Falls, which provides up to 12 sessions with a physiotherapist over 12 months and supports participants to engage in individualised exercises. Both arms will receive educational resources in the participant’s preferred language. The primary outcome is implementability of the co-designed intervention, MOVE Together: Reduce Falls; operationalised as fidelity (>70% of intended sessions delivered), feasibility (> 95% of sessions delivered with no serious adverse events related or likely related to the intervention) and acceptability (>50% acceptability score). The secondary outcome is feasibility of the RCT protocol, which will be evaluated quantitatively (eg, recruitment and retention rates, completion of clinical outcome data including prospective collection of falls data for 12 months via falls calendars) and qualitatively (eg, barriers and enablers to data collection).

Ethics and dissemination

Ethical approval has been granted for this study (HREC/106010/MH-2024). Study findings will be published in peer-reviewed journals and presented at relevant conferences and community forums.

Trial registration number

ACTRN12624000658516.

Smoking, nicotine and pregnancy 3 (SNAP3) trial: protocol for a randomised controlled trial of enhanced support and nicotine replacement therapy (NRT) offered for preloading, lapse recovery and smoking reduction in pregnancy

Por: Campbell · K. A. · Clark · M. M. · Montgomery · A. A. · Partlett · C. · Dickinson · A. · Bradshaw · L. · Jones · M. · Huang · Y. · Aveyard · P. · Jiang · Y. · Holmes · C. M. · Coleman · T.
Introduction

Nicotine replacement therapy (NRT) helps pregnant women quit smoking. Usual National Health Service (NHS) cessation care in pregnancy starts only after women stop smoking and comprises behavioural support and NRT. NRT is stopped if women restart smoking. We hypothesised that NRT would have a bigger effect on cessation in pregnancy if used: (1) to reduce smoking before quitting (‘preloading’), (2) during brief smoking lapses after quitting and (3) to help those who cannot stop smoking, to reduce instead.

Methods and analysis

A two-arm parallel group, open-label, multicentre, assessor-blind randomised controlled trial. Participants are recruited at hospital antenatal clinics and other NHS settings throughout England and Wales or via social media advertising. Those enrolled are in antenatal care,

Ethics and dissemination

Ethics approval was granted by the West Midlands—Coventry & Warwickshire Research Ethics Committee (REC reference: 21/WM/0172; Protocol number 21001; IRAS Project ID: 291236). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice and policy representatives and other researchers.

Trial registration number

ISRCTN84798566.

Mixed-methods longitudinal evaluation of the mental health first aid (MHFA) for freshman university students in Hong Kong: a study protocol

Por: Capio · C. M. · Kwok · M. K. · Liu · T. W. · Wong · W. K. · Wong · J. Y.-H.
Introduction

The mental health first aid (MHFA) training is an evidence-based programme that is known to improve undergraduate students’ attitudes towards mental illness and confidence in helping people with mental health problems. MHFA training will be implemented at a university in Hong Kong to address growing concerns about mental health challenges among students. Given the context of a university-wide systematic MHFA training implementation, this evaluation uses an intervention logic framework to evaluate the processes and longitudinal outcomes.

Methods and analysis

A mixed-method approach will be used where the quantitative component will gather data from a review of records and a case-control study for outcome evaluation; the qualitative component will gather data from individual interviews. All first-year students from the university in the academic year 2024–2025 (ie, September 2024 to August 2025) will be enrolled in the mandatory MHFA training. The outcome evaluation will assess effectiveness through short-, intermediate- and long-term outcomes. An online questionnaire will be distributed to the students before (pre) and immediately after (post) the MHFA training. For comparison, second-year students who had not participated in MHFA training will be invited to complete the same online questionnaire. The questionnaires will be administered further to those who completed the MHFA training at 12 months (ie, academic year 2025–2026) and 24 months (ie, academic year 2026–2027) post-training to evaluate intermediate-term and long-term effects, respectively. The process evaluation explores feasibility, fidelity, adoption and the barriers and enablers to implementation.

Ethics and dissemination

This evaluation has been approved by the Human Research Ethics Committee of Hong Kong Metropolitan University (reference number HE-SF2024/35). The findings are expected to contribute to establishing long-term effects on mental health literacy and on the actual mental health support actions provided by participants, which goes beyond the intention to help. This evaluation would also facilitate a better understanding of the processes that need to be considered in a systematic MHFA training implementation in a university context. The findings will be disseminated in academic and public health community settings.

Data statement and project registration

This project has been registered in the Open Science Framework. Fully anonymised data will be saved and subsequently made available through the following OSF registration: https://doi.org/10.17605/OSF.IO/92N5Q.

PLAN-psoriasis: protocol for a randomised controlled feasibility trial comparing patient-led 'as-needed treatment and therapeutic drug monitoring-guided treatment to continuous treatment for adults with clear or almost clear skin on risankizumab monothera

Por: Ye · W. · Powell · K. · Dooley · N. · Thomas · C. M. · Coker · B. · McAteer · H. · Wei · J. R. · Tan · W. R. · Baudry · D. · Dasandi · T. · Pizzato · J. · Sach · T. H. · Gregory · J. · Yang · Z. · Pink · A. E. · Woolf · R. T. · Warren · R. B. · Weinman · J. · Barker · J. N. · Chapman · S. · St
Introduction

Targeted biologic therapies have transformed outcomes for individuals with psoriasis, a common immune-mediated inflammatory skin disease. The widespread use of these highly effective treatments has led to a growing number of individuals with clear or nearly clear skin remaining on continuous, long-term treatment. Personalised strategies to minimise drug exposure may sustain long-term disease control while reducing treatment burden, associated risks and healthcare costs. This study aims to evaluate the feasibility of a definitive pragmatic effectiveness trial of two personalised dose minimisation strategies compared with continuous treatment (standard care) in adults with well-controlled psoriasis receiving the exemplar biologic risankizumab.

Methods and analysis

This is a multicentre, assessor-blind, parallel group, open-label randomised controlled feasibility trial in the UK, evaluating two personalised biologic dose minimisation strategies for psoriasis. 90 adults with both physician-assessed and patient-assessed clear or nearly clear skin on risankizumab monotherapy for ≥12 months will be randomised in a 1:1:1 ratio to (1) patient-led ‘as-needed’ treatment, where risankizumab is administered at the first sign of self-assessed psoriasis recurrence, (2) therapeutic drug monitoring-guided treatment, with personalised dosing intervals determined using a pharmacokinetic model or (3) continuous treatment as per standard care, for 12 months. Participants will be invited to submit self-reported outcomes and self-taken photographs every 3 months using a bespoke remote monitoring system (mySkin app) and will attend an in-person assessment at 12 months. They may also request additional patient-initiated follow-up appointments during the trial if needed. The primary outcome is the practicality and acceptability of the two personalised biologic dose minimisation strategies, assessed as a composite measure including recruitment and retention rates, adherence to the assigned strategies and acceptability to both patients and clinicians. The feasibility of collecting healthcare cost and resource utilisation data will also be evaluated to inform a future cost-effectiveness analysis. A nested qualitative study, involving semistructured interviews with patients and clinicians, will explore perspectives on the personalised biologic dose minimisation strategies. These findings will inform the design of a future definitive trial.

Ethics and dissemination

This study received ethical approval from the Seasonal Research Ethics Committee (reference 24/LO/0089). Results will be disseminated through scientific conferences, peer-reviewed publications and patient/public engagement events. Lay summaries and infographics will be codeveloped with patient partners to ensure the findings are accessible for the wider public.

Trial registration number

ISRCTN17922845.

Trimodal age distribution of frequent attendance at the emergency department: a descriptive analysis of national, English, secondary care data using a retrospective cohort

Por: Marshall · C. · Kumar · A. · Saraiva · S. · West · R. M. · Mason · S. M. · Burton · C. D. · van der Feltz-Cornelis · C. M. · Lee · W. · Bojke · C. · Mattock · R. · de la Haye · S. · Relton · S. D. · Guthrie · E.
Objectives

Frequent use of emergency departments (EDs) places a considerable burden on healthcare systems. Although frequent attenders are known to have complex physical, mental health and social needs, national-level evidence on their characteristics and patterns of attendance remains limited. This study aimed to provide a comprehensive, population-level description of frequent ED attendance in England, with a focus on age-based subgroups.

Design

Retrospective cohort study.

Setting

EDs in England via the Hospital Episode Statistics and the Emergency Care Dataset data linked with primary care prescribing and mortality data, between March 2016 and March 2021.

Participants

The dataset received from National Health Service Digital contained approximately 150 million ED attendances by 30 million adult (>18 years) patients over the time period April 2016 to March 2021. A random sample of 5 million people was used for this analysis.

Outcome measures

The primary outcome was the number of attendances in each financial year by frequent attenders compared with the remaining patients, split by age bands. Patients were classified as frequent attenders if they had ≥5 or ≥10 ED attendances within a rolling 12-month period. Secondary outcomes included demographic, diagnostic and prescribing characteristics, as well as the number of different ED sites visited.

Results

A Gaussian mixture model was used to identify age-based subgroups. Descriptive statistics were used to summarise key features; 95% CIs were reported where applicable. Among 3.91 million unique adult ED attenders, there were 8.7 million attendances. Of these, 222 160 individuals (5.7%) had ≥5 attendances in a year, accounting for 12.6% of total attendances. A trimodal age distribution was identified, with three distinct peaks corresponding to ages 18–34, 35–64 and 65+. Frequent attenders were more likely to live in deprived areas and have a history of psychotropic or analgesic prescribing. Mental health diagnoses and polypharmacy were particularly common in the younger and middle-aged groups. Multisite attendance was uncommon, with over 80% of frequent attenders using only one ED site annually.

Conclusions

This national analysis reveals a trimodal age pattern among frequent ED attenders, with differing clinical and socio-demographic profiles across age groups. These findings highlight the need for age-tailored approaches to managing high-intensity ED use and inform targeted service development.

Reference standard for the prevention and management of hospital falls: a multidisciplinary Delphi consensus study

Por: Morris · M. E. · Said · C. M. · Haines · T. · Heng · H. W. F. · Batchelor · F. · Hutchinson · A. M. · McKercher · J. P. · Semciw · A. I. · Hill · A.-M. · Peterson · S. · Kane · R. · Fowler-Davis · S. · Campbell · S. · Sherrington · C. · Gilmartin-Thomas · J. · Phan · U. · Thwaites · C.
Background

Hospital falls persist as a major threat to patient safety. This study aimed to develop an interprofessional reference standard to prevent, manage and report hospital falls.

Methods

A Delphi consensus methodology, informed by the Conducting and Reporting Delphi Studies guideline, was used to design the reference standard. An interprofessional expert panel (n=47) of health professionals, researchers, policymakers and consumers participated in three Delphi rounds. Following the review of clinical guidelines, an e-Delphi survey was developed and piloted to derive 60 initial items for the standard. Two iterative rounds of e-Delphi surveys were distributed via Research Electronic Data Capture and included free-text questions and 9-point Likert scales. An online consensus meeting followed, to ratify the final standard.

Results

In the first Delphi round, there was over 80% agreement for 44/60 items to be included in the reference standard. This increased to 48/60 items in Round 2. At the final consensus meeting, 12 items still did not reach consensus for inclusion and one was added, yielding 49 items. Items that replicated text according to falls with injury/without injury were combined, resulting in 42 items in the final reference standard. Agreed items included: (1) brief screening of falls risk on hospital admission; (2) comprehensive falls assessment for inpatients who are older, frailer or have complex conditions; (3) single interventions (such as environmental adaptations and exercise); (4) multifactorial interventions; (5) education of patients, families and staff; (6) optimising local falls hospital policies, procedures and leadership capability; (7) optimising documentation and reporting; (8) improving accreditation processes; (9) workforce redesign to augment falls education. Items that did not reach agreement (n=12) pertained to alarms, bed rails, grip socks, artificial intelligence, volunteers and care bundles.

Conclusion

This new reference standard provides a checklist for staff, patients, managers and policymakers to reduce unwanted variations in prevention, management and reporting of hospital falls.

Trial registration number

ANZCTR 386960

Scalability evaluation of a complex community-based falls prevention intervention in Australian stroke rehabilitation

Por: Lin · I. · Day · S. · Dean · C. M. · Clemson · L. M. · Glinsky · J. V. · Cusick · A. · Lannin · N. A. · Scrivener · K.
Objectives

To investigate the scalability of the multi-component Falls After Stroke Trial (FAST) intervention tailored to community-dwelling adults with stroke to enable post-trial implementation.

Design

A mixed-methods formative evaluation of FAST data guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework.

Setting

Community settings across three states in Australia.

Participants

Stroke participants were a subset of FAST trial participants (n=50) who were community-dwelling adults who had experienced a stroke up to 5 years prior and were at risk of falling. Therapists who delivered the intervention in the trial (interventionists) were physiotherapists and occupational therapists, trained in the FAST intervention.

Interventions

The FAST intervention is an individually tailored home safety and functional exercise programme designed to reduce falls and improve community mobility. It is offered over a 6-month period using 10 home visits, two telephone calls and programme resources, for example, manual and worksheets.

Primary and secondary outcome measures

Trial data, including interventionist training records and delivery data, resources and stroke participants’ adherence data were used to assess the Adoption, Implementation and Maintenance dimensions of the RE-AIM framework.

Results

The FAST intervention was delivered by 22 interventionists. High implementation fidelity was shown with 90% of the stroke participants receiving FAST dose and content. Effective strategies supporting implementation included standardised programme resources, comprehensive pre-programme training, regular interventionist feedback and interventionist mentoring from experts. Online training and peer support networks will be required for scale up.

Conclusions

This study identifies how a complex intervention to prevent falls after stroke was successfully delivered. The AIM dimensions provided insights to FAST features essential for scale-up. Interventionist training, resources and mentoring/feedback were essential for adoption within the trial. Training and resources should be accessible in an online format for scale up (maintenance).

Trial registration number

ACTRN12619001114134.

Health and social service use by adults before and after cochlear implantation: a national population-level retrospective cohort study in Australia

Por: Okuba · T. · Lystad · R. P. · Boisvert · I. · McMaugh · A. · Moore · R. C. M. · Wolnizer · P. · Chow · C. · Walson · R. · Mitchell · R.
Objective

To examine health and social service use pre- and post-cochlear implant in adults.

Design

A retrospective cohort study.

Setting

All public and private hospitals in Australia.

Participants

A total of 3033 adults aged ≥18 years who received a cochlear implant in Australia between 1 January 2014 and 31 December 2018 were included. Participants were followed for 3 years pre-implant date and 3 years post-implant date or until death. Data were sourced from the Person Level Integrated Data Asset.

Primary and secondary outcome measures

The study examined the (i) number of visits to general practitioners (GPs), specialists and audiologists; (ii) fee charged, benefit paid and out-of-pocket (OOP) expenses for health services; (iii) personal income; (iv) completion of higher education and post-high school vocational education and training and (v) number of government benefits and concession cards received.

Results

The mean age of adults at cochlear implantation was 63.3 years (SD 16.1). Over the 3 years period before and after implantation, the mean number of GP visits remained stable (24.5 pre-implant vs 24.7 post-implant), specialist visits decreased (6.4 pre-implant vs 5.3 post-implant) and audiologist visits increased (1.7 pre-implant vs 6.6 post-implant). Higher GP visit rates were observed both pre- and post-implantation among females (RR 1.13 vs 1.14), older adults (RR 1.06 vs 1.15), individuals needing assistance with daily activities (RR 1.11 vs 1.12), individuals with chronic health conditions (RR 1.25 vs 1.34), with ≥6 RxRisk comorbidities (RR 2.35 vs 2.22) and adults residing in socio-economically disadvantaged areas (RR 1.64 vs 1.19). Mental health conditions were associated with increased specialist visits pre- and post-implantation (RR 2.57 vs 2.53), while employed individuals had higher specialist visit rates post-implantation (RR 1.58). Average OOP costs for health services decreased by 31.4% post-implant. Government benefits were higher pre-implant (55.6%) than post-implant (44.4%). Females and adults needing assistance with activities of daily living were more likely to seek government benefits.

Conclusions

These findings highlight the need for tailored healthcare and social support services to address the diverse needs of cochlear implant users, ensuring comprehensive care and support throughout their healthcare journey.

Two years and counting: a prospective cohort study on the scope and severity of post-COVID symptoms across diverse patient groups in the Netherlands--insights from the CORFU study

Por: Klein · D. O. · Waardenburg · S. F. · Janssen · E. B. N. J. · Wintjens · M. S. J. N. · Imkamp · M. · Heemskerk · S. C. M. · Birnie · E. · Bonsel · G. J. · Warle · M. C. · Jacobs · L. M. C. · Hemmen · B. · Verbunt · J. · van Bussel · B. C. T. · van Santen · S. · Kietelaer · B. L. J.
Importance

Little research has been done on post-COVID symptoms at 24 months postinfection and on the association these may have on health-related quality of life (HRQOL).

Objective

We assessed the prevalence and severity of post-COVID symptoms and quantified EuroQol 5 Dimension 5 Level (EQ-5D-5L), self-perceived health question (EuroQol Visual Analogue Scale (EQ-VAS)) and health utility scores (HUS) up to 24 months follow-up.

Design

The longitudinal multiple cohort CORona Follow-Up (CORFU) study combines seven COVID-19 patient cohorts and a survey among the general public. The participants received questionnaires on several time points. Participants were stratified by: without a known SARS-CoV-2 infection (control group), proven SARS-CoV-2 infection but non-hospitalised, proven SARS-CoV-2 infection hospitalised to the ward, and proven SARS-CoV-2 infection hospitalised to the intensive care unit (ICU).

Setting

In this study, data of seven COVID-19 patient cohorts and a survey among the general public are included.

Participants

Former COVID-19 patients and controls participated in this cohort study.

Main outcomes and measures

Former COVID-19 patients and non-COVID-19 controls were sent questionnaires on symptoms associated with post-COVID condition. The CORFU questionnaire included 14 symptom questions on post-COVID condition using a five-level Likert-scale format. Furthermore, HRQOL was quantified using the EuroQol EQ-5D-5L questionnaire: EQ-VAS and the EQ-5D-5L utility score. The EQ-5D-5L questionnaire includes five domains that are scored on a five-point Likert scale: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Results

A total of 901 participants (and 434 controls) responded at 24 months follow-up. In all former COVID-19 patients, the presence of post-COVID condition at 24 months was observed in 62 (42.5%, 95% CI 34.3% to 50.9%) of the non-hospitalised patients, 333 (65.0%, 95% CI 60.7% to 69.2%) of the hospitalised ward patients and 156 (63.2%, 95% CI 56.8% to 69.2%) of the ICU patients, respectively (p

Conclusions

Many former COVID-19 patients experience post-COVID symptoms at 24 months follow-up, with the highest prevalence in hospitalised participants. Also, former patients reported a lower HRQOL.

Trial registration number

The CORFU study was registered at clinicaltrials.gov (registration number NCT05240742).

'For the love of God, just refer me: a co-produced qualitative study of the experiences of people with Tourette Syndrome and tic disorders accessing healthcare services in the UK

Por: Babbage · C. M. · Davies · E. B. · Jones · D. P. · Stevenson · P. · Salvage · J. · Anderson · S. · McNally · E. · Groom · M. J.
Objectives

Chronic tic disorders (CTDs)—such as Tourette Syndrome (TS)—are neurodevelopmental disorders affecting at least 1% of the population, causing repetitive involuntary movements and vocalisations known as tics. This study aimed to explore the lived experiences of accessing healthcare for people with CTD or TS and their families in the United Kingdom (UK), as part of a larger programme of work to inform change to healthcare services for this population.

Design

Informed and designed with extensive patient and public involvement, the design utilised qualitative research using focus groups. Reflexive thematic analysis was used to analyse the data.

Setting

Participants were recruited via online support groups, social media and research registers.

Participants

Seven focus groups were held separately with young people with tics (n=2), adults with tics (n=10) and parents/guardians of children with tics (n=11), led by a lived experience expert (coauthor PS) and facilitated by researchers. Discussion focused on three areas: the impact of living with tics, experience accessing healthcare for tics and management of tics.

Results

Five themes were developed highlighting challenges across the healthcare pathway, including gaining a diagnosis, and receiving treatment, resulting in the use of self-support methods to reduce tic expression or the impact of tics. Themes also illustrated perceptions that healthcare provider's knowledge impacted initial interactions with the healthcare system, and how healthcare systems were not felt to be prioritising CTDs.

Conclusions

The findings highlight a lack of prioritisation for tic disorders compounded by a healthcare structure which does not support a complex condition that requires a multidisciplinary approach. This research calls for improvements to UK healthcare services for CTD.

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