Patient decision aids (PtDAs) are effective interventions to support patient involvement in health decisions and have the potential to impact favourably on health inequities by reducing gender bias in clinical practice. The aim was to explore sex and gender reporting and differences in randomised controlled trials (RCTs) evaluating PtDAs for adults making treatment or screening decisions.

Secondary analysis of the Cochrane review of PtDAs of RCTs that reported sex and/or gender. The original review searched MEDLINE, Embase, PsychINFO and EBSCO from journal inception to March 2022. Two team members independently screened citations, extracted data and assessed risk of bias. For this secondary analysis, we only included primary outcomes from the original review. We assessed appropriate use of terminology for sex (biological attribute) and gender (social construct). When terms were used interchangeably, it was considered inaccurate. Findings were synthesised descriptively, and we used meta-analysis when two or more RCTs were conducted with females/women or males/men using similar outcome measures.

Informed values-choice congruence and the quality of the decision-making process (eg, knowledge, accurate risk perceptions, feeling informed, clear values, participation in decision making, undecided) and adverse events (eg, decision regret, emotional distress) by sex and gender.

Of 209 RCTs in the original review, 206 reported sex and/or gender, with 35 (17%) using accurate terminology. Of 206 RCTs, 70 were with females/women only, 27 males/men only, 12 analysed by sex/gender and 97 RCTs did not disaggregate findings by sex or gender. Meta-analysis comparing RCTs for females/women to usual care and RCTs for males/men only compared with usual care showed similar mean differences in knowledge scores (10.84 vs 9.38 out of 100; p=0.44). Males/men had significantly higher self-reported participation in decision making compared with females/women (RR 3.16 vs 0.95; p

In PtDA RCTs, sex and gender terms are used interchangeably and 6% analysed outcomes by sex or gender. Meta-analysis of males/men only given PtDAs showed higher self-reported decision making participation in clinical practice compared to usual care versus females/women only compared with usual care. Researchers must improve reporting sex and gender in PtDA RCTs to assess how it influences health inequities.

With the global lymphatic filariasis (LF) elimination goal set to 2030, it is necessary to address challenges hindering the last-mile efforts. Never treated individuals are those who self-report that they have never taken the drugs for LF during any mass drug administration (MDA) rounds. Hence, it is necessary to identify these individuals and assess if they can be potential reservoirs of infection and understand the reasons for non-compliance.

This mixed method study, proposed for a period of 2 years, will assess the filarial infection status of never treated individuals from four LF-endemic districts in India. A multi-stage cluster sampling design will be followed to select the health subcentres from one highly endemic block in each of the selected districts. A random sample of 2535 never treated individuals from each block will be assessed for filarial infection by a cross-sectional blood survey. Qualitative surveys, including in-depth interviews and focus group discussions, will be conducted to elicit the reasons for their non-compliance. The prevalence of filarial infection will be summarised as frequencies and percentages. Univariate and multivariate logistic regression analysis will be performed to find the factors associated with filarial infection. Exploring the various reasons, such as sociocultural, behavioural and programmatic drivers of non-participation, will enable the programme to design tailored communication and community engagement strategies to bring them under the umbrella of MDA and thereby support the ongoing LF elimination efforts.

This study has been approved by the institutional ethics committee (IHEC 07-0824/N/F, dated 25 September 2024). After completion of the study, a workshop will be held with all stakeholders to disseminate the study findings.

Debilitating Symptom Complexes Attributed to Ticks (DSCATT) is a new term for an unexplained Australian syndrome—people who suffer from a chronic, multifaceted and debilitating illness, characteristically attributed to tick bites, but in a country without endemic Lyme disease. Despite the profound morbidity of DSCATT, no single causative agent has been identified and there are no recognised treatments for the illness at present. An increasing body of evidence shows psychological therapies such as Acceptance and Commitment Therapy (ACT) can be effective in reducing symptom-related disability and improving quality of life for other unexplained syndromes. Here we present a study protocol to assess the feasibility of an ACT-informed intervention for patients suffering from DSCATT, to be used adjunctively to their pre-existing healthcare. The study aims to assess the acceptability, practicality and demand for the treatment. Additionally, we will examine the effects of therapy on participants’ health and well-being, its safety, potential mediators of response to therapy and its preliminary cost-effectiveness.

We will assess the feasibility of a 32-week, randomised, waitlist-controlled, parallel convergent mixed-methods pilot trial for DSCATT. Participants will be randomised in a 1:1 ratio to receive either 16 sessions of ACT-informed therapy adjunctive to their pre-existing healthcare, delivered one-to-one with a trial therapist within a 20-week period or be assigned to the waitlist control group where they will continue their treatments as usual. We will collect quantitative and qualitative data to address study aims, with retention rate being the primary feasibility outcome.

The study has ethical approval from Austin Health Human Research Ethics Committee (HREC). The outcomes will be published in peer-reviewed journals. Data from participants who have given extended consent will be available for other HREC-approved studies.

ACTRN12623000372684, prospectively registered 13 April 2023, URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385579&isReview=true; the last participant is expected to complete in November 2026.

To assess the impact of a National Enhanced Service (NES) incentive for weight management that financially rewarded practices for each eligible patient referred to a weight management programme.

Interrupted time-series analysis to examine the rate of weight management referral and weight management advice.

Primary healthcare records from January 2018 to December 2024 in the Oxford Clinical Informatics Digital Hub, covering 8.3 million patients in 1198 primary care clinics around England.

NES payments to practices for weight management were introduced in April 2021.

The rate of referral increased from 1 referral per 1000 patients per month before the incentive to around 4 referrals per 1000 patients per month afterwards. There was no evidence that the increase differed by age, gender, ethnic group or socioeconomic status. The occurrence of weight management advice was unchanged by the introduction of the NES and was at least three times more common than referral to weight management services.

The NES was associated with a fourfold increase in referrals to weight management services. However, clinicians are much more likely to offer advice rather than a referral to a weight management programme. There is a clear opportunity to improve outcomes for patients by encouraging greater use of referrals to effective weight management services in place of advice.

Previous reviews have investigated the relationship between empathy and burnout. However, these are now out of date, did not capture the effect of the pandemic, did not include healthcare professionals other than doctors and nurses or medical students, did not assess the impact of differences in profession and did not pool the data, which made estimating the strength of the association unclear. We therefore aim to address these shortcomings in an up-to-date, rigorous, systematic review and meta-analysis.

Findings will be reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines and flowchart.

We will search American Psychological Association (APA) PsycINFO, APA PsycArticles, Cumulative Index to Nursing and Allied Health Literature (CINAHL), The Cochrane Library, PubMed and Scopus. We will also search ResearchSquare and Social Science Research Network (SSRN) for preprints; ProQuest Dissertations and Theses and Electronic Theses Online Service for relevant theses. Forward and backward citation searches will identify additional studies. Two independent reviewers will screen titles, abstracts and full texts and extract data. Two independent reviewers will assess risk of bias using Risk of Bias 2 (RoB 2) for randomised controlled trials, Risk of Bias in Non-randomised Studies of Interventions (ROBINS-I) for non-randomised interventional studies and Risk of Bias in Non-randomised Studies of Exposures (ROBINS-E) for observational studies.

For all included studies, we will summarise the study characteristics, including number of participants; health profession, specialty and career stage; country and gender. If data are suitable, we will pool results and conduct subgroup analyses (including by health profession, career stage and clinical specialty). We will also explore the relationships between subscales of empathy and burnout. We will use metaregression to explore the impact of theoretically derived factors (such as study design and profession) on the strength of the association. Sensitivity analyses will assess the impact of low-quality research. In our discussion, we will summarise results, the limitations and provide a general interpretation of the results and implications.

Ethical approval is not required for this review, as primary data will not be collected. The review will be disseminated through peer-reviewed publication and presentation at conferences.

CRD420251075618.

Peripheral artery disease (PAD) affected approximately 800 000 Canadians aged 25 years or older in 2015 and it poses a substantial risk of lower extremity amputation (LEA). While clinical risk factors for amputation are well-established, the impact of social determinants of health (SDoH) on amputation risk remains unclear, particularly in a Canadian context.

This systematic review aims to: (1) synthesise evidence on the associations between multilevel SDoH domains and LEA (both major and/or minor) risk in Canadian PAD patients including intersectional effects of race and ethnicity with another SDoH domain, and (2) evaluate the statistical methodologies used in the researched literature to inform future study design and analysis approaches.

We will systematically search MEDLINE, Embase, EmCare, Global Health, Cumulative Index to Nursing and Allied Health Literature and Web of Science for studies examining SDoH and LEA in Canadian patients with PAD (including chronic limb-threatening ischaemia which is a severe form of PAD). Date limits for each database will be from inception through December 2025. SDoH will be categorised using a modified Healthy People 2030 SDoH framework under six domains: economic stability, education, food, neighbourhood and physical environment, healthcare system and community and social context. Two reviewers will independently screen titles, abstracts and full texts, with discrepancies resolved by a third reviewer. Data will be extracted on study characteristics, SDoH measures, outcomes and statistical methods. Risk of bias will be assessed using RoB 2 for randomised trials, ROBINS-I for non-randomised studies of interventions and ROBINS-E for studies investigating exposures. A narrative synthesis, and where data permit, a Bayesian hierarchical meta-analysis using both effect size and contingency table approaches will be conducted. Statistical heterogeneity will be explored through subgroup analyses and meta-regression, examining study design, SDoH measurement approaches and population characteristics.

As a systematic review and meta-analysis, ethics approval is not required. For institutional oversight, we provide the contact of Dr Sonia Anand (Associate Vice-President, Global Health, McMaster University; anands@mcmaster.ca). Results will be reported following PRISMA guidelines and disseminated through a peer-reviewed publication.

CRD420251115759.

Inadequate production of the essential stress hormone, cortisol, results in adrenal insufficiency (AI), which is associated with significant morbidity and mortality. The current standard diagnostic test for AI is the Short Synacthen Test (SST), but this is both invasive and resource-intensive, involving cannulation and blood sampling. A novel formulation, Nasacthin, has been developed in which the same Active Pharmaceutical Ingredient can be delivered intranasally, with the resultant glucocorticoid levels either measured in serum, or in saliva samples to render the test non-invasive, thus creating a potentially more cost-effective test. The Salivary Test of Adrenal Response to Liquid Intranasal Tetracosactide (STARLIT-3) study aims to determine the diagnostic utility of the test in patients with AI.

STARLIT-3 is a randomised 2-way crossover trial which aims to collect data from 32 AI patients allocated to receive both Synacthen and Nasacthin in a random order across two study visits. Paired blood and saliva samples will be collected from participants at baseline, and then at 30 and 60 min after drug administration. Glucocorticoid levels in study samples will be quantified with the aim to determine whether the Nasacthin test is able to correctly diagnose patients with AI by estimating the positive percent agreement with the standard SST using serum cortisol at 30 and 60 min. Data on any reported harms and on the acceptability, usability and tolerability of the Nasacthin test will also be collected.

The study and subsequent amendments have been reviewed and approved by South Central—Hampshire A Research Ethics Committee. Results will be published in peer-reviewed journals and presented at national and international conferences. Plans for dissemination of results to trial participants will be developed in collaboration with patient and public involvement and engagement groups.

ISRCTN26461337.

All children in England should receive a health review at 2–21/2 years, with the Ages and Stages Questionnaire third edition (ASQ-3) used to collect public health surveillance data on child development. However, practitioners also value tools that assess individual children’s development—consistent with ASQ-3’s original purpose. Concerns about licensing costs and barriers to digitalisation have prompted interest in alternative tools to the ASQ-3 in England.

To inform policy, we conducted a rapid scoping review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines to identify tools that can measure or assess early child development.

Searched PubMed, PsycINFO and Web of Science from January 2012 to November 2022, with targeted search update November 2024.

We included English-language studies published after January 2012 that described or evaluated tools in English which could measure or assess early child development in children

We extracted key features and reliability, validity, sensitivity and specificity of tools which could feasibly be implemented at the 2–21/2-year review (eg, including multiple age versions and

We identified 112 unique publications describing 34 tools; six met our feasibility criteria for the 2–21/2-year review (reported in 53 studies). Only ASQ-3 and CREDI offer domain-specific scoring—a government priority. ASQ-3 moderately detects mild delays and performs better for severe delays in at-risk groups. Caregiver Reported Early Development Instruments (CREDI) was designed for public health surveillance, and we do not yet know how it performs for individual assessment.

ASQ-3 and CREDI are most promising for use at the 2–21/2-year review. However, we lack UK-based validation and norming studies, even for ASQ-3. Ultimately, careful implementation and integration into existing systems will determine a tool’s value for identifying developmental needs, supporting families and producing high quality data for public health surveillance.

India targets to eliminate lymphatic filariasis (LF) in alignment with the global goals. By 2024, 106 out of a total of 345 endemic districts have passed all three serial transmission assessment surveys (TAS) and are under post-mass drug administration (MDA) surveillance for a variable period. However, the current epidemiological situation of LF is not known in these districts. With increased mobility of population from the endemic districts currently under MDA to these post-MDA areas, resurgence of LF in these areas cannot be ruled out. Therefore, a study is planned to understand the current LF status in areas under post-MDA surveillance with the following objectives: (1) To assess the epidemiological situation of LF in terms of human and vector infection prevalence in selected evaluation units (EUs) under different durations of post-MDA phase and (2) to estimate the filarial infection (in terms of filarial antigen and microfilaria) among migrants (from endemic districts) in these EUs.

This cross-sectional study will measure the filarial infection in (1) adult population aged ≥20 years (following the WHO 2025 protocol for monitoring and evaluation of MDA) among general population (n=3150 per EU), (2) migrant population (aged 2 years and above) in the post-MDA area originating from endemic areas (n=1000 per EU) and (3) vectors (n=7500 per EU) using molecular xenomonitoring (MX) to confirm sustenance of transmission interruption or identify any potential risk of resurgence in three EUs under post-MDA phase. In one MDA-naive EU that shares borders with endemic districts, filarial infection status will be assessed in (1) school children aged 9–14 years (as per WHO mini-TAS protocol, n=480), (2) migrants (aged 2 years and above) from endemic areas (n=1000) and (3) vectors (n=7500). EU-wide prevalence of microfilaria, circulating filarial antigen and vector infection rates with 95% CIs will be estimated. Multivariate logistic regression analysis will be carried out to find factors associated with LF positivity. In addition, knowledge, attitude and practice surveys will also be conducted among the adult migrants (n=1000 per EU). Thirty in-depth interviews will be conducted among the migrants, local community and health workers (in each EU) and the results will be suitably analysed and triangulated. The study results will enable the national programme to confirm sustenance of transmission interruption or assist in taking a decision to reinitiate MDA in these areas under post-MDA surveillance. It will also enable devising specific strategies to treat migrants.

This study has been approved by the institutional ethics committee (IHEC 03-0824/N/F). A workshop will be held with all stakeholders to disseminate the study findings.

Personalised nutrition that incorporates genetic results into dietary interventions holds significant potential to optimise weight management and metabolic outcomes. While traditional calorie-restricted diets remain effective, emerging evidence suggests that variations in macronutrient distribution may offer additional benefits. Genetic variants help explain interindividual differences in dietary responses, with certain alleles showing enhanced weight loss and metabolic improvements with specific macronutrient distributions. However, comprehensive reviews of randomised controlled trials (RCTs) examining genotype-based dietary effects, particularly those focusing on macronutrient distribution metabolic pathway interactions, are lacking, limiting the development of robust evidence-based guidelines for nutrigenetic counselling. This systematic review aims to assess the influence of genetic variants on weight loss outcome in adults in response to varying macronutrient distribution diets (eg, low-fat, low-carbohydrate, high-protein diets) using evidence from RCTs.

We will systematically review RCTs examining weight loss outcomes of macronutrient-varied diets in adults with genotype stratifications to risk and protective allele. Multiple databases, PubMed, Cochrane Library, Scopus, Science Direct and Google Scholar, will be used. Reviewers will screen studies, extract data on study characteristics, weight loss, metabolic marker outcomes and genetic data, and assess the risk of bias using the Cochrane Risk of Bias Tool 2.0 tool.

All eligible RCTs will first be summarised in structured tables describing study characteristics, macronutrient distribution and genetic variants and will be analysed with narrative synthesis. For quantitative analysis, interventions will be grouped into three predefined diet types (high-protein, low to moderate carbohydrate and low-fat diet). Because heterogeneity across diet categories is expected, pooled effects will be estimated separately within each diet subgroup using random-effects meta-analysis, expressed as mean differences in weight change (kg). Within each subgroup, and when at least 10 studies or data are available, random-effects meta-regression will be used to examine potential moderators, including intervention duration, physical activity and ancestry. Heterogeneity will be evaluated using I² and ², and publication bias assessed when feasible. Evidence certainty will be graded using Grading of Recommendations Assessment, Development and Evaluation.

Ethical approval is not required for this protocol as it involves the analysis of data from primary studies. The findings will be disseminated through publication in peer-reviewed journals. Any enquiries regarding research integrity of this protocol may be directed to the Head of the Doctoral Program in Medical Health and Sciences, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada via the institutional email address s3fk@ugm.ac.id, as the responsible academic authority for research integrity.

CRD420251050587.

Leprosy remains a significant public health challenge in many low and middle-income countries, including India. People affected by leprosy face multifaceted challenges: physical, psychological, social and economic. In response, donors support self-help groups (SHGs) to improve health, social integration and economic circumstances for marginalised people, including those with leprosy. This study aims to assess the sustainability of SHGs in India after the withdrawal of donor support by examining whether they remain functional and exploring the key factors, barriers and facilitators that influence their long-term social and economic viability.

To examine the functionality of SHGs after withdrawal of donor support, and to explore the factors, barriers and facilitators influencing their long-term social and economic sustainability.

Using qualitative methods, we conducted semistructured interviews with 40 key informants associated with five SHGs formed under the Self-Help Community Development Project implemented in an endemic state of India and funded by The Leprosy Mission Trust India.

It was an exploratory qualitative study using interviews with SHG members and key informants, situated within the self-help community-based project.

While some SHGs demonstrated resilience and adaptability, others faced challenges such as internal discord, loss of members to migration and lack of access to government schemes. Thematic analysis revealed key drivers and barriers to sustainability and realising the benefits of SHGs, highlighting variations in leadership, governance, economic performance and social engagement across groups.

SHGs are often sustained after the funding and managerial donor support have been withdrawn. The findings emphasise the importance of strong leadership, community support and external facilitation in sustaining SHGs and enhancing their impact on marginalised populations. This study contributes to understanding the role of SHGs in addressing the socioeconomic challenges faced by individuals affected by leprosy and offers insights for improving their long-term viability.

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.

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.

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.

Immigrant populations, particularly undocumented immigrants, are often considered ‘hidden’ or ‘hard to reach’ in research. This invisibilisation—under-representation or exclusion in data collection—leads to data inequities and biased findings that fail to capture their unique experiences. Starfish sampling mitigates selection bias and improves access to invisibilised populations by recruiting ‘seed’ participants at randomly selected times and locations and leveraging their social networks to recruit the next wave of participants. In this protocol paper, we outline the sampling strategy for the BRAVE (Building community, Raising All immigrant Voices for health Equity) study, a multi-site, cross-sectional survey examining the relationship between immigration history and sexual and reproductive health (SRH) service utilisation among Asian immigrant women in the USA. This protocol is an adaptation of novel starfish sampling in combination with various data tools and a community-based participatory research approach.

Using data from the American Community Survey and insights from community partners, we will conduct community mapping across four study sites (Atlanta, Houston, Los Angeles County and New York City). We will select census tracts that reflect the primary ethnic groups of interest and diverse socioeconomic backgrounds. From these selected census tracts, we will construct a venue universe by identifying key activity areas for Asian immigrant women through data scraping from online sources. We will then randomly select venue-date-time combinations and deliberately choose various community engagement events for recruitment. Culturally competent field officers who are fluent in Asian languages will recruit participants at these events. Participants can refer up to three peers from their social networks to take part in the survey. Results will be presented as descriptive statistics and logistic regression models to test the association between immigration history and SRH service utilisation.

The overarching BRAVE study protocol was approved by the University of California Los Angeles Institutional Review Board (IRB) (IRB-22–0493-AM-016). The results will be disseminated through academic journal publications and relevant data will be shared with our community partners.

This research aimed to explore student paramedics’ experiences of participating in group-based simulation activities used as part of their summative assessment. It sought to understand their perceptions of the effectiveness of group-based simulation in fostering learning and informing future assessment design.

A qualitative questionnaire-based study.

A UK higher education institution.

A total of 34 first-year (level 4) student paramedics from the September 2022 to September 2023 cohorts.

Following the completion of a summative assessment for the introduction to non-technical skills and simulation module, students were invited to reflect on their experiences of group-based simulation through an online questionnaire. The assessment incorporated team-based simulation scenarios intended to evaluate non-technical competencies within a realistic and supportive environment.

Four key themes emerged through thematic analysis of the responses: experiential learning; autonomous learning; reflective learning; and support and learning. These themes provide insights into the pedagogical value of group-based simulation, with students identifying both individual and collective benefits in developing non-technical skills within a group assessment framework.

Group-based simulation assessments enhance student engagement and promote collaborative decision-making in a context that mimics real paramedic practice. While students often associate realism with increased confidence, their experiences highlight complex interactions between perceived fidelity, assessment pressure and learning. This underscores the need to further investigate how group dynamics and authenticity influence learning outcomes in assessment-focused simulations.

Cisplatin is a widely used chemotherapeutic anti-cancer drug. However, high-dose cisplatin is also known for its dose-limiting toxicities, including irreversible cisplatin-induced hearing loss (CIHL). Sodium thiosulphate (STS) can bind to cisplatin to form an inactive and harmless complex. A topical application is desired, allowing cisplatin to retain its systemic anti-cancer effect.

The SOUND trial is an investigator-initiated randomised controlled multicentre phase III trial to study the efficacy of transtympanic administration of STS against CIHL in a cohort of 100 patients with head and neck cancer treated with cisplatin at a dose of ≥200 mg/m². Each subject will receive transtympanic STS injections in one ear, chosen by randomisation, before each cisplatin infusion. The contralateral ear serves as an internal control. The primary objective is efficacy (ie, clinically relevant benefit) of transtympanic STS injections against CIHL, defined as a difference in threshold shift of ≥10 decibels between baseline and 3 months after treatment in favour of the STS-treated ear. Secondary objectives include the difference in mean threshold shifts on frequencies essential for speech and extended high frequencies, as well as the difference between both ears in the gradation of hearing loss as defined by ototoxicity grading scales.

The medical ethics committee in the Netherlands approved the trial (Clinical Trials Information System (CTIS) 2023-503313-30-00). The results will be disseminated through the CTIS and peer-reviewed scientific journals.

CTIS 2023-503313-30-00 approved by Medical Research Ethics Committee NedMec.

Cancer screening appointments are an opportunity to encourage positive behavioural changes. Up to 80% of cancer screening attendees are open to discussing physical activity during cancer screening, but some say this would deter them from future screening. This study aimed to gain an in-depth understanding of individuals’ receptivity to physical activity advice at cancer screening.

Interview-based qualitative study.

The study was conducted from May 2017 to September 2018 in the UK. Participants were recruited using adverts on two university campuses, Facebook and a participant recruitment agency. To be eligible, participants had to have an upcoming cancer screening appointment within 2 weeks. There were 30 participants.

Participants recorded their receptivity to physical activity advice in the days before and after screening. Data-prompted semi-structured interviews explored these responses. Interviews were analysed using a thematic framework analysis.

Participants felt discussing physical activity at cancer screening would be relevant. However, participants experienced anxiety related to the screening process which could increase or decrease their receptivity. Participants felt if information was delivered in a judgemental way, it could negatively impact future screening participation.

Screening attendees’ receptivity could be influenced by the timing of a discussion and by their levels of anxiety throughout screening. Participants’ anxiety during screening can either reduce their ability to engage in a discussion or increase the relevance of the discussion. The communication style of the healthcare practitioner was key for why some screening attendees could be deterred from future cancer screening.

Lynch syndrome (LS) carriers have a 20–46% lifetime risk of colorectal cancer (CRC) due to mismatch repair gene variants. Mesalamine (5-ASA, 5-aminosalicylic acid), used safely in patients with ulcerative colitis, may reduce CRC risk in LS by decreasing microsatellite instability, a key driver of LS-related cancer. This study evaluates 5-ASA’s efficacy as a tolerable chemopreventive drug, aiming to improve long-term CRC prevention in LS.

This multicentre, multinational, randomised, double-blind, two-arm, phase II clinical study will compare the effects of a 2-year daily intake of 5-ASA (2000 mg) to placebo in LS carriers. The primary objective is to assess whether mesalamine reduces colorectal neoplasia, both benign and malignant, compared with placebo in LS carriers, as detected by colonoscopy at the end of the treatment period (24 months±1 month) and on study completion. Secondary objectives include evaluating whether 5-ASA reduces neoplasia/tumour multiplicity and progression compared with placebo at specified time points, examining variations in the effects of 5-ASA versus placebo based on cancer history, sex and age (

The trial is currently open for enrolment, having received ethical approval from the Regional Ethical Review Board in Stockholm and funding from the Swedish Research Council. The study protocol is the finalised V.10.0 (11 April 2024), transitioned to the European Clinical Trials Information System. LS remains underdiagnosed, which may limit recruitment. The results are of global interest and will be published in peer-reviewed journals and presented at scientific conferences.

ClinicalTrials.gov: NCT04920149. EudraCT: 2019-003011-55. EU CT: 2024-514765-19-01.

Fibrosis is a pathological feature that can occur in a wide range of diseases including diabetes mellitus. We investigated whether in people with type 1 (T1DM) or type 2 diabetes mellitus (T2DM), glycaemia or diabetes-related complications are associated with fibrotic diseases.

Retrospective cohort study using UK Clinical Resource Datalink (CPRD) Aurum and Hospital Episode Statistics.

We included people with prevalent T1DM or T2DM as of 31 December 2015 (recorded in CPRD Aurum), eligible for linkage with Hospital Episode Statistics and followed up for 3 years.

We defined diabetes status using blood/urine biomarkers and complications. In the T2DM cohort, we also investigated exposures of hyperglycaemia, insulin resistance and metformin prescription. Fibrotic condition diagnoses were determined from both primary and secondary care records. Logistic regression analyses were undertaken to understand the strength of association between diabetes status/diabetic complications and fibrotic conditions, respectively.

The T1DM cohort consisted of 9669 people while the T2DM cohort included 504 066 people. In T1DM, we found that albuminuria was associated with lung fibrosis (ORadj: 2.07, 99% CI 1.35 to 2.17), and microvascular complications were associated with atherosclerosis (ORadj: 1.81, 99% CI 1.18 to 2.77) and cardiomyopathy (ORadj 1.53, 99% CI:1.15 to 2.04). In the T2DM cohort, both glycaemia above target and diabetes complications were associated with most fibrotic conditions.

Within the T1DM population, no consistent association between diabetes status and all fibrotic diseases was observed. More research is required to understand whether the association between diabetes complications and fibrotic diseases is due to shared risk factors or whether glycaemia in T2DM may be influenced by fibrotic pathology.

Hearing loss is highly prevalent and impacts many aspects of a person’s life, including communication, social engagement, employment, general health and well-being. Yet, many people do not access hearing healthcare and are unaware of the range of hearing healthcare options available. Barriers to hearing healthcare include poor understanding of hearing loss and its impact; poor knowledge of help-seeking for hearing healthcare options; minimal support to help decide which option is best; and stigma related to hearing loss. These barriers lead to many people not receiving the hearing healthcare they need. Guided by theories of behaviour change and implementation science, HearChoice, an online tailored decision support intervention, has been co-developed to empower adults with hearing difficulties by offering them choice and control over their own hearing healthcare. HearChoice aims to facilitate informed decisions, accessibility and uptake of hearing healthcare, including a wide range of interventions, for adults with hearing difficulties. The objectives of the trial are to evaluate the effectiveness, health economics and feasibility of HearChoice.

This online randomised controlled trial will recruit participants with hearing difficulties across Australia, with an anticipated sample size of 640. Participants will be randomised to either HearChoice (treatment) or an Australia-specific Hearing Option Grid (active control), both delivered online. Outcomes will be assessed at baseline when the interventions will be offered, at 7 days post-intervention (primary endpoint) and at 3 months post-intervention. An email reminder will be sent at 1-month post-intervention. The primary outcome is decisional conflict. Secondary outcomes include measures of readiness and self-efficacy to take action, hearing-related quality of life and empowerment, assessment of the value and impact of HearChoice, work performance and health, and feasibility measures. Primary analysis will compare outcomes between HearChoice and the active control at the primary endpoint.

The study was approved by the Curtin University Human Ethics Committee (HRE2023-0024). All participants will provide written informed consent prior to participation. A broad dissemination plan of the study findings includes peer-reviewed publications, scientific conference presentations, articles and presentations for the wider community and public written in lay and accessible language, and social media.

Australian New Zealand Clinical Trials Registry (ACTRN12624001139561).

Engaging patients in surgical safety is challenging and has not been thoroughly investigated. Although surgical checklists and other safety protocols have been introduced across various surgical fields, preventable adverse events still occur, highlighting the need for additional research. A Patient’s Safety Checklist (PASC) has been developed and validated for use by surgical patients. Its effect on patient safety and patient outcomes is currently being investigated in a Stepped Wedge Cluster Randomised Controlled Trial (NCT03105713). In connection with this trial, we have examined elective patients’ experiences with using the PASC.

An exploratory qualitative study was conducted based on individual in-depth telephone interviews with 31 elective surgical patients. The interviews were carried out across three Norwegian hospitals including seven surgical specialties. The patients interviewed were part of the trial’s intervention arm and had used PASC. The interviews were transcribed verbatim, and reflective thematic analysis was applied.

Three themes were identified in the data: patient awareness, patient actions and utility value. Patients perceived PASC to increase awareness around surgical information, preparations, what to speak up about and which information to seek and repeat. This awareness led to a series of actions, such as ensuring medication control, optimising their own health, contacting healthcare professionals, asking questions, and for some no actions were needed. Patients perceived PASC to have high utility value for their surgical preparation.

The PASC enhanced patients’ involvement in surgical care and safety by ensuring they received systematic, accurate, clear, and understandable information and instructions throughout the surgical pathway. It is one of the few existing interventions that specifically focuses on assisting patients in preparing for surgery and managing their recovery. Further research is needed on the implementation of PASC and its adaptation to other clinical settings.

NCT03105713.