Interstitial lung diseases (ILDs) represent a heterogeneous group of disorders, which have in common persistent inflammation and/or pulmonary fibrosis, involving mainly but not exclusively the interstitium. This results in restrictive ventilatory physiology and limited respiratory reserve. Patients with ILD can have frequent exacerbations of their disease, with subsequent acute respiratory failure that may require admission to the intensive care unit (ICU). The diagnosis and management of ILD in the ICU presents unique challenges due to the paucity of evidence supporting survival benefits of organ support in this cohort of patients.

This systematic review will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, and the protocol will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guideline. MEDLINE, Embase, Emcare and CENTRAL will be searched for studies published from inception to 2026, involving adult patients with ILD requiring invasive mechanical ventilation (IMV), with or without comparison to non-invasive respiratory support such as high-flow oxygen, non-invasive ventilation (NIV), continuous positive airway pressure or bilevel positive airway pressure. Eligible studies will include randomised controlled trials and observational studies (cohort and case–control) in adults with ILD and acute respiratory failure requiring IMV in the intensive care setting. Case series with fewer than 10 patients, non-human or in vitro studies and studies involving perioperative lung transplant or lung cancer as the primary diagnosis will be excluded. The primary outcomes assessed will be in-hospital and 1-year mortality, and secondary outcomes will include ventilator-free days, ICU and hospital length of stay, NIV failure, reintubation and postdischarge respiratory outcomes where available. Where feasible, meta-analysis will be conducted using a random-effects model. Heterogeneity will be assessed using the I² statistic. Prespecified subgroup analyses will be performed, including ILD subtype (eg, idiopathic pulmonary fibrosis (IPF) vs non-IPF), presence of pulmonary hypertension, timing of IMV initiation (early vs late), baseline lung function (forced vital capacity ≥50% vs

This systematic review will be based on published data, and as such, no ethical approval is required. Findings from this study will be disseminated through peer-reviewed publications as well as presentations in healthcare-based settings.

CRD420251265836.

The United Nations (UN) Sustainable Development Goal 6 seeks to ensure universal access to safe drinking water by 2030, but vast inequities in access exist, especially among vulnerable communities including limited resource, rural, disaster-affected areas. Flood disasters, exacerbated by the climate crisis, hinder the ability of individuals and families to meet essential drinking water needs and increase their susceptibility to waterborne illnesses. Point-of-use (POU) water treatment is an effective solution for water-insecure populations during and immediately following flood emergencies. However, an initial literature search identified knowledge gaps surrounding implementation of POU water systems. This scoping review aims to synthesise published evidence between January 2015 and July 2025 on barriers and facilitators to utilisation of POU water treatment systems during and immediately following flood-related disasters. The findings will inform efforts to promote resilience and agency among water insecure communities, specifically by equipping them with actionable knowledge on sustainable access to safe drinking water.

This scoping review will be guided by the work of Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Search terms will be identified through an iterative process using the PICOT method and Boolean logic. Four databases—Scopus, PubMed, Web of Science and Google Scholar—with the addition of grey literature from UN agencies and non-governmental organisations focused on water-related issues will be searched. Two independent reviewers will apply a priori eligibility criteria to select studies. Conflicts will be resolved through discussion and a third independent reviewer absent agreement between the first two reviewers. Cohen’s kappa statistic will be calculated to assess inter-rater reliability. Data extraction will be guided by predefined data points, and the Consolidated Framework for Implementation Research will guide evidence synthesis through a solution-based approach.

Institutional research ethics review is not required because no human subjects are involved. Findings will be disseminated through a peer-reviewed publication, a policy brief, conference presentations and infographics for use by organisations serving flood disaster impacted communities.

In many countries, a high or increasing rate of sickness absence is challenging the sustainability of present sickness absence benefit schemes. Most sickness absence is certified on the grounds of common mental disorders or musculoskeletal disorders, and substantial effort has been invested in developing interventions promoting return to work for these patients. In Norway, the Health in Work ((HelseIArbeid), HIA) clinics were established as outpatients’ services within the specialised healthcare system, with the aim of improving health and supporting return to work. The HIA service admits patients with low-to-moderate anxiety/depression and/or musculoskeletal disorders. In this protocol, we describe the naturalistic multicentre randomised controlled trial Norwegian Sickness Absence Clinic Efficacy study, which aims to determine the effect of HIA on work participation and health.

The HIA outpatient service is staffed by clinical psychologists, physiotherapists, medical specialists in physical medicine and rehabilitation and employment support supervisors from the Norwegian Labour and Welfare Administration. Patients admitted to HIA have access to multidisciplinary assessment and treatment. The trial recruits’ patients from five HIA outpatient clinics in Northern Norway. Patients are randomised in equal proportions to either (1) rapid HIA (assessment within 4 weeks), (2) delayed HIA (assessment within 10–14 weeks) or (3) active control, which consists of a monodisciplinary examination at HIA close to diagnosis-specific deadline for examination as suggested by guidelines (8–26 weeks). The trial commenced recruitment on 16 January 2023 and will recruit 2500 patients. The aim is to assess the effect of the HIA service, with the hypothesis that the HIA concept is superior to what resembles treatment as usual, in improving employment and preventing long-term welfare dependency. Secondary outcomes include self-reported symptoms of health problems. We also examine the effect the service has on other healthcare utilisation. To date, no research has been conducted to assess the efficacy of the HIA service. If proven efficacious, and if there is an economic case for this investment in tailored healthcare delivery, the policy implication may be implementation of the service at scale. If not, adaptations or investments into other viable paths of treatment may be considered.

The study is approved by the Regional Committee for Medical Research Ethics (REC North, #122770). Results from the study will be disseminated at national and international scientific conferences, to funders and participating outpatient clinics in seminars and in peer-reviewed scientific journals.

NCT05310695.

Obesity and related cardiometabolic comorbidities, including hypertension, dyslipidaemia, diabetes, metabolic dysfunction-associated steatotic liver disease and atherosclerotic cardiovascular disease, are increasingly prevalent among individuals with inflammatory bowel disease (IBD). These conditions influence disease activity, therapeutic response, surgical outcomes and overall quality of life, yet evidence remains fragmented. The Modulate Obesity and relateD metabolic complIcations For Yielding improvements in IBD outcomes (MODIFY-IBD) initiative aims to synthesise evidence and generate consensus recommendations to guide practice and future research in this area. This study describes a protocol for a structured evidence synthesis and Research ANd Development/University of California, Los Angeles (RAND/UCLA) Appropriateness Method (RUAM) consensus process.

We will conduct three systematic reviews and a structured evidence synthesis organised into three domains: (1) the impact of obesity on IBD outcomes, (2) the burden of cardiometabolic complications in IBD and (3) the management of overweight, obesity and cardiometabolic comorbidities in IBD. A multidisciplinary international panel of gastroenterologists, surgeons, endocrinologists, hepatologists, cardiologists and dietitians will assess each statement using the RAND/UCLA appropriateness method. Panellists will rate the appropriateness of each statement (only those that fall within their area of expertise) on a 1–9 scale (1–3=inappropriate, 4–6=uncertain and 7–9=appropriate), with medians rounded up (eg, 6.5=appropriate). Agreement will be assessed using the RAND Disagreement Index (DI

This study will not involve direct patient participation, as it is based on evidence synthesis and expert consensus; therefore, formal research ethics committee approval will not be required. Patient representatives will contribute to the consensus process to provide contextual perspectives but no identifiable data will be collected.

Findings will be disseminated through publication in peer-reviewed journals, presentation at major gastroenterology and IBD conferences and communication with professional societies. A lay summary and patient-friendly infographic will also be developed to facilitate translation of recommendations into clinical practice.

CRD420251178843: a systematic review of the impact of obesity on inflammatory bowel disease outcomes.

CRD420251178799: a systematic review of cardiometabolic complications in inflammatory bowel disease.

CRD420251174653: management of overweight, obesity and cardiometabolic comorbidities in inflammatory bowel disease: a systematic review.

Masculinising chest surgery, also known as top surgery, is the most requested gender-affirming procedure among transgender and gender-diverse (TGD) adolescents, yet research on patient experiences remains limited. This study explored the experiences of TGD adolescents who were seeking or had undergone masculinising chest surgery.

Qualitative secondary analysis using existing themes framework and data from the GENDER-Q (GQ) and GENDER-Q Youth (GQY) research programmes, which aim to develop comprehensive patient-reported outcome measures for gender-affirming care.

Participants were sampled from five high-volume gender-affirming care clinics, three in Canada and two in the United States. Interviews were conducted online.

35 GQ and GQY participants aged 13–18 years who were assigned female at birth, identified as trans men or non-binary, and were pursuing (n=19) or had undergone (n=16) masculinising chest surgery.

Three major themes emerged: chest appearance, health-related quality of life (HRQL) and gender practices. Most participants expected a flatter chest that aesthetically aligned with their gender identity. Presurgery participants anticipated that surgery would allow them to engage in previously avoided physical activities and would enhance their relationships. Postoperative participants reported increased physical activity, mental resilience, bodily connection and social comfort. Most reported binder use and related reliance or discomfort as motivators for pursuing surgery.

This study highlights the multidimensional experiences surrounding masculinising chest surgery on TGD adolescents with impacts on chest appearance, HRQL and gender practices. Centering adolescents’ perspectives, these findings underscore the importance of accessible, affirming surgical care and provide valuable insights for clinicians, policymakers and future research.

Perinatal depression is a common, yet understudied, mental health disorder among women and contributes to poor engagement in prevention of mother-to-child transmission (PMTCT) of HIV in sub-Saharan Africa. Male partners are positioned to provide critical forms of social and economic support during pregnancy and postpartum, and also may contribute to women’s stress, depression and anxiety through intimate partner violence and withholding of social support. Despite the critical role of men in pregnancy outcomes and HIV prevention, few interventions have engaged men around women’s depressive symptoms, nutrition and health, and engagement in PMTCT. We will conduct a pilot trial of Mphatso, a couple-based intervention based on problem-solving therapy with couple relationship skills to reduce depressive symptoms in perinatal women, improve food insecurity and prevent HIV transmission to the infant.

We will employ a two-arm pilot randomised controlled trial in the Zomba district of Malawi to assess the feasibility and acceptability of Mphatso (meaning ‘gift’ or the child) and explore health impacts on depressive symptoms, PMTCT engagement and food insecurity. We will enrol 60 pregnant women in the second or third trimester who are living with HIV and meet criteria for probable depression based on the Edinburgh Postnatal Depression Scale and their male partners. Couples will be randomised to receive either five sessions of Mphatso (problem-management skills plus health education and relationship skills) or enhanced usual care. Feasibility and acceptability outcomes will include session attendance rates, satisfaction levels and retention at 3 months and 6 months postpartum. Exploratory analyses using regression models including time and treatment arm will be conducted to explore effects on the mothers’ and fathers’ depressive symptoms, adherence to PMTCT (antiretroviral therapy, nevirapine use, HIV testing and exclusive breastfeeding) and food insecurity.

The pilot trial has been approved by the University of California, San Francisco (Human Research Protection Program (HRPP); Protocol Number 23-40685), and the study has also been approved by the National Health Sciences Research Committee in Malawi (NHSRC; Protocol Number 24/05/4431). Results will be disseminated to study participants, health officials, policymakers, community leaders and care providers, as well as through presentations at conferences and publications in peer-reviewed journals.

NCT06659315.

A resurgent methamphetamine epidemic is a major driver of HIV incidence in the USA. Although daily oral pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV acquisition, its effectiveness depends on achieving and maintaining prevention-effective adherence (ie, four or more doses per week). Digital health interventions offer a scalable method to extend the reach of behavioural approaches to HIV prevention, but evidence of their efficacy in improving objectively measured adherence remains limited. Addressing this gap is critical to maximising the clinical and public health benefits of PrEP.

From 26 January 2022 through 17 January 2025, this single-blind, parallel-group randomised controlled trial (RCT) enrolled 239 men taking PrEP who reported problematic stimulant use and who resided in California or Florida. Participants were randomised to receive five individually delivered telehealth sessions of a positive psychological intervention (n=119) or an attention-control condition (n=120), both delivered alongside remote contingency management for directly observed PrEP doses using the Spotlight mobile health application. Participants received US$20 per session and up to US$360 for uploading videos of at least four PrEP doses per week over 3 months. Follow-up assessments at 3, 6 and 12 months included surveys and dried blood spot specimens to quantify tenofovir diphosphate (TFV-DP). The primary outcome is biobehavioural HIV acquisition risk, defined as any recent condomless anal sex in the absence of TFV-DP concentrations consistent with prevention-effective adherence.

This RCT was approved by the University of Miami Institutional Review Board and registered prior to initiation of enrolment. Analyses of primary and secondary outcomes using intent-to-treat principles will be conducted after the completion of TFV-DP assays in June 2026, with results disseminated shortly thereafter through peer-reviewed publications.

This RCT was registered on www.clinicaltrials.gov (NCT04899024) prior to launching enrolment.

While improvements have been made across the HIV care continuum in South Africa, gaps remain. Relationship-focused couples-based approaches may be one avenue to improve HIV-related outcomes for men and women. Prior couples-based studies have been found to improve several HIV care and treatment outcomes in this context, but few have considered viral suppression as the primary outcome. We aimed to compare a couples-based motivational-interviewing intervention delivered to couples to similar content delivered to men and women in couples separately. We will test the efficacy of this approach in a randomised controlled trial.

Our goal is to enrol 270 heterosexual couples for this trial, with at least one partner living with HIV. Couples will be randomised into one of two arms, stratified by couples’ HIV status. The intervention arm, Simunye (‘We are one’ in isiZulu), will provide two sessions of motivational information and skills regarding HIV-related behaviours to couples together, along with relationship-focused content and skills. The content is based on Partner Steps (P-steps), a couples-focused adaptation of Life Steps, an evidence-based programme shown to improve adherence and viral suppression. The control group will receive two sessions as individuals, with similar HIV-related information but without relationship-focused content. Participants will be followed up at 6, 12 and 18 months postrandomisation. The baseline questionnaire will include measures of relationship domains such as satisfaction and communication, and measures pertaining to HIV and reproductive health (eg, fertility intentions, HIV knowledge and risk perception, and sexual behaviour), and mental health (eg, depression symptoms). The primary outcome is viral suppression, based on dried blood spots. Secondary outcomes will include other aspects of treatment engagement. We will also examine hypothesised mediators of intervention participation, for example, relationship dynamics. Primary analyses will use a multilevel modelling approach, which will feature planned time-averaged comparisons of postbaseline measurements across the intervention and control groups to test the primary hypothesis. The analysis will account for the dyadic nature of the data, for example, participants nested within couples.

This trial was approved by the Institutional Review Board (IRB) at the Human Sciences Research Council in South Africa, protocol number 2/27/01/21, and the IRB at the University of Michigan (HUM 00203672). Human subjects’ concerns or adverse events will be reported to both IRBs and the Data Safety and Monitoring Board. We will disseminate findings to community members and stakeholders via community meetings, as well as by conference presentations and publications in peer-reviewed journals.

Clinicaltrials.gov Protocol Registration NCT05231707 registered on 8 February 2022. Protocol version 2.0, 31 October 2025.

Immunosuppression is associated with an increased risk of delayed SARS-CoV-2 viral clearance, severe COVID-19 and related death. This heterogeneous group of affected patients includes but is not limited to those with a haematological malignancy, people on immunosuppressive therapy for the treatment of autoimmune/inflammatory diseases and those following bone marrow transplantation (BMT). Immunosuppression is associated with decreased rates of anti-spike IgG seroconversion following COVID-19 vaccination. While clinical guidelines have been established to guide vaccination pre-splenectomy and post-BMT, there are limited data to guide timing of COVID-19 or other booster vaccines in adults commencing new or intensified moderate to severe immunosuppression. The comparison of immunity-boosting regimens for COVID-19 upon initiation of immunosuppressive therapy (CIRCUIT) study was designed to address this knowledge gap. CIRCUIT investigates whether administration of a third (or subsequent) COVID-19 booster vaccine ≤2 weeks prior to immunosuppression provides greater anti-spike IgG-mediated immunity than a booster given 24 weeks after new or intensified immunosuppression, that is, week 24 timepoint (Group 1; n=280). Additionally, the research will investigate whether giving a fourth post-BMT COVID-19 booster vaccine at 9 months post-transplant provides greater anti-spike IgG-mediated immunity than a booster given 15 months post-transplant (Group 2; n=40).

The CIRCUIT study is an open-label, multicentre randomised clinical trial. Participants will be randomised 1:1 to receive either an additional COVID-19 booster ≤2 weeks pre-immunosuppression and a diphtheria/tetanus toxoids (DT) booster at 24 weeks following new or intensified immunosuppression (week 24 timepoint) or receive a DT booster ≤2 weeks pre-immunosuppression and an additional COVID-19 booster at week 24 (Group 1). Group 2 participants who underwent autologous or allogenic BMT in the last 9 months will be randomised 1:1 to either receive a fourth post-BMT COVID-19 booster at 9 or 15 months post-transplant. The primary outcome will be the integrated time-weighted area under the curve anti-SARS-CoV-2 neutralising antibody (NAb) response over 12 months from a SARS-CoV-2 booster as assessed by a high-throughput SARS-CoV-2 NAb platform assay. Key secondary outcomes of the CIRCUIT randomised control trial will include safety and generation of SARS-CoV-2 antigen specific T and B cell responses.

The research protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee on 25 August 2022 (Ref no. 2022/PID00782 – 20022/ETH0069). Study results will be published in peer-reviewed medical journals and presented at local and international conferences. All findings regardless of the outcome will be reported.

NCT05415267.

Healthcare services are mainly organised around single health conditions and need reconfiguration to meet the needs of people with multiple long-term conditions (multimorbidity). Typically, people are offered annual reviews for each of their long-term conditions separately. In a randomised controlled trial, a comprehensive computerised template based on a personalised care model increased the person-centredness of multimorbidity reviews in primary care, but there were implementation challenges. We sought to understand and address the challenges of implementing a template to support personalised primary care for people with multimorbidity (PP4M).

To explore the extent of implementation and factors influencing uptake of the PP4M intervention. To understand factors influencing implementation and normalisation of the template.

Convergent parallel mixed methods within a non-randomised hybrid implementation-effectiveness study. Normalisation Process Theory (NPT) informed design, data collection and analysis.

Primary care (general practices) in three English regions.

Quantitative: Patients aged 18 years or over and had at least three types of long-term conditions (routine data collection); staff involved in using the template in implementation practices (Normalisation MeAsure Development (NoMAD) questionnaire).

Qualitative: Staff at implementation practices.

A multimorbidity computerised template to support personalised annual reviews. NPT-informed implementation package delivered to implementation practices included: process mapping, software support and training.

Routine medical record data; NoMAD questionnaires and qualitative interviews in implementation practices.

Measures of reach, fidelity, acceptability and sustainability.

Quantitative data: descriptive statistics, logistic regression and difference-in-difference models. Qualitative data analysis conducted using NPT coding manual.

In practices that received an NPT-informed implementation package, use of the template increased more, across patients with a range of demographics and health conditions, than in those that did not receive the implementation package (OR 2.86 (95% CI 2.34 to 3.49)). The implementation package successfully triggered NPT processes of coherence and cognitive participation, and, to a lesser extent, collective action and reflexive monitoring. Contextual factors, including a lack of staff generalist skills and disease-specific incentives, impeded engagement and sustained implementation.

Focusing on the processes of normalisation as mechanisms of implementation facilitated development of an implementation strategy with potential to trigger those mechanisms, but did not sufficiently address contextual factors. Implementation strategies to support personalised care must consider wider system and practice level contextual factors, such as incentives and staff training.

https://doi.org/10.1186/ISRCTN40295449 (2022–08-03, retrospectively registered.)

Emergency general surgery (EGS) decisions often occur under time pressure and with reduced patient involvement in comparison to the elective setting. Variation in decision-making in the field of EGS is partly attributable to patient and contextual factors, but clinician factors also likely shape decisions.

This scoping review aims to clarify which clinician factors have been investigated in relation to decision-making in adult EGS, which have been identified as influential, and the methods used to measure them.

Any studies reporting on individual clinician factors and decision-making in EGS will be eligible. Studies must be only in adult populations (patients aged 18 and over). This review will consider quantitative, qualitative and mixed-methods study designs.

This scoping review will be conducted in accordance with the methodology developed by the Joanna Briggs Institute and reported in accordance with Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. This protocol was prospectively registered with the Open Science Framework: https://osf.io/xcqp4. We will search MEDLINE, EMBASE, CINAHL, CDSR and CENTRAL. The search strategy will be adapted for each database, and no time or language restrictions will be applied.

Two independent reviewers will screen studies for eligibility and extract data using a purpose-designed data extraction form, with disagreements resolved by a third reviewer. Extracted data will be synthesised using a narrative approach to map key concepts, describe study characteristics and identify gaps in the literature.

Ethical approval is not required as this review will use publicly available data. Findings will be disseminated through peer-reviewed publication and conference presentations.

The Needs Assessment Tool-Cancer (NAT-C) is a consultation guide to identify, triage and reduce unmet patient needs.

We aimed to assess NAT-C fidelity, mechanisms of action and implementation issues in UK primary care as part of a clinical and cost-effectiveness cluster randomised controlled trial of the NAT-C for people with cancer compared with usual care (registration: ISRCTN15497400).

Design: a mixed-methods process evaluation informed by normalisation process theory (NPT). Setting: 21 participating general practices in England were randomised to be trained to conduct an NAT-C guided consultation with people with cancer (excluding those in remission). General practitioner fidelity of intervention and clinical action resulting from the NAT-C consultation was noted. Two Normalisation MeAsure Development Questionnaire surveys were distributed to trained clinicians before (Survey 1) and after delivery of ≥2 NAT-C consultations (Survey 2). Semi-structured interviews were conducted with clinicians (post delivery ≥2 NAT-C consultations) and key stakeholders in primary and cancer care. Fidelity, action and paired before/after survey data were analysed using descriptive statistics. Interview data were analysed using a deductive thematic framework approach (NPT-informed). Data were narratively synthesised with cross-tabulated key findings.

Of the 360/376 (96%) NAT-C consultations delivered, 258/360 (72%) resulted in clinical action, including 50 (13%) external referrals. 14 paired before (Survey 1, n=53) and after (Survey 2, n=29) responses. Survey 1 showed positive responses across all NPT domains, but while continuing to see relevance, usefulness and legitimacy, Survey 2 highlighted concerns about insufficient resources and management support. 16 clinician participants (eight GPs, eight key stakeholders; 50% male) completed interviews. Following synthesis, we identified five themes: (1) the perceived value of the NAT-C; (2) ‘champions’ are important at all levels (practice, regionally and nationally); (3) research evidence is seen as important, but influences implementation indirectly through policy, clinical guidelines and resourced initiatives; (4) adequate resources are fundamental for implementation beyond practice level and (5) NAT-C practicalities; training is adequate, but robust functional information technology systems are needed.

Implementation requires champions and clinicians ‘buy-in’ to the patient value to legitimise use. In the context of current primary care pressures, resources were seen as essential to embed the NAT-C, but financial incentives were viewed with mixed feelings.

ISRCTN15497400.

Primary care is facing multiple crises, including an increase in health misinformation. Digital health messaging by primary care providers has been shown to reach a diverse patient population. With the uptake of Generative Artificial Intelligence (GenAI) usage in healthcare, there is an important opportunity to rapidly create messages that are tailored to different populations and conditions. However, thoroughly assessing artificial intelligence (AI)-generated content is essential, as GenAI raises concerns regarding its accuracy, understandability, actionability and bias perpetuation. We aim to investigate whether digital health messages created by GenAI are evaluated as non-inferior compared with those created by human experts.

The AI-CARE (AI to Create Accessible and Reliable patient Education materials) study is a double-blind, crossover, non-inferiority randomised controlled trial. Data collection began on 30 May 2025, and is expected to be completed at the end of May 2026. Over 12 months, 192 messages on 48 topics will be written: half by primary care and public health experts and half by a GenAI tool (OpenAI’s ChatGPT). Review Panels composed of 24 primary care providers and 24 patients will evaluate these messages using an Evaluation Grid developed to assess the messages’ quality of information, adaptation to the target audience, relevance and usefulness, and readiness to be shared with patients. Evaluations will be completed via online REDCap (Research Electronic Data Capture) surveys and the order in which the 192 messages appear will be randomised and will vary between individuals. Participants and analysts will be blinded to the generation source. The primary outcome will be the Clarity and Understandability score.

The Research Ethics Boards of the Hôpital Montfort (24-25-11-038) and the University of Ottawa (S-12-24-11153) formally approved this study in December 2024. Reported data will be grouped and anonymised for dissemination in peer-reviewed scientific journals and conferences.

NCT06997107.