To identify enablers and barriers for scaling up non-communicable disease (NCD) interventions across diverse global contexts and to map these factors to the WHO’s health system building blocks.

A multi-method qualitative study applying the Consolidated Framework for Implementation Research to analyse data from multiple projects nearing or completing scale-up.

Global Alliance for Chronic Diseases-funded implementation research projects conducted across 18 low- and middle-income countries and high-income settings.

Data was derived from documents (n=77) including peer-reviewed publications, policy briefs, and reports and interviews with stakeholders (n=18) (eg, principal investigators, medical professionals, public health workers).

Various context-specific interventions targeting sustainable scale-up of NCD (eg, diabetes, hypertension, cardiovascular disease) interventions at the community, primary care or policy levels.

The primary outcome was identifying contextual enablers and barriers to intervention scale-up. Secondary outcomes included exploring how these factors aligned with health system building blocks (eg, leadership/governance, healthcare workforce).

Twenty enablers (eg, intervention adaptability, strong stakeholder engagement, local empowerment) and 25 barriers (eg, resource limitations, intervention complexity, stakeholder burnout) were identified. Contextual alignment, supportive governance and capacity building were critical for sustainability, while cultural misalignment and socio-political instability frequently hampered scaling efforts.

Tailoring interventions to local health systems, ensuring stakeholder co-ownership and incorporating strategies to mitigate stakeholder burn-out are essential to achieving sustainable, scalable NCD solutions. Future research should focus on integrating systematic cultural adaptation, sustainable financing and workforce capacity building into scale-up planning.

Process evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial.

We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes’ findings.

The study protocol was approved by the Wake Forest University School of Medicine Institutional Review Board (IRB). Findings from this study will be disseminated through peer-reviewed journals and scientific conferences.

NCT05828823.

Hospital patients are at an increased risk of falls, which are a significant safety concern within healthcare settings.¹ Understanding how the COVID-19 pandemic has influenced fall risks is essential for identifying key factors that could inform future fall prevention strategies.² This scoping review aims to explore the barriers and challenges associated with preventing inpatient falls in the context of the post-COVID-19 environment.

The methodology for this scoping review follows the framework established by Arksey and O’Malley. A comprehensive literature search will be conducted using specific keywords to identify relevant published studies. Searches will be performed across selected electronic databases, including PubMed/MEDLINE, CINAHL, Scopus, ProQuest and Web of Science, covering publications from 2014 to 2024. This review will focus on a global perspective. Two authors will independently screen titles and abstracts to identify potential studies for inclusion. Studies meeting the inclusion criteria will be retrieved for full-text review, and their references will be assessed for relevance using the same criteria. The PRISMA flow diagram will guide the review process. Data will be extracted, analysed and charted according to categories from the selected publications.

This scoping review will provide a comprehensive overview of the barriers and challenges in preventing inpatient falls in the post-pandemic context. The findings will be disseminated through submission for publication in a scientific journal.

This scoping review protocol is registered with Open Science Framework (OSF) available at https://osf.io/.

On 1 January 2023, Ontario expanded pharmacists’ scope of practice, allowing them to prescribe medications for 13 minor ailments, including antibiotics for uncomplicated urinary tract infections (UTIs) and Lyme disease (LD) prophylaxis. This study evaluates pharmacist billing claims and pharmacist and physician antibiotic-prescribing rates before and after policy implementation.

An interrupted time series analysis measuring changes in prescribing trends post-implementation.

This retrospective study analysed visit claims and antibiotic prescribing for UTIs and LD prophylaxis before policy implementation (2022) and after (2023–2024) in Ontario.

Data from Ontarians

Prescribing rates were standardised per 1000 inhabitants, stratified by provider type, patient age and sex, and antibiotic type.

In 2023 and 2024, pharmacists submitted over 1.47 million minor ailment claims, with UTIs making up 34.2% and LD prophylaxis making up 2.6% of total claims. UTI claims were primarily for women aged 25–64, and LD prophylaxis peaked in spring and fall. Pharmacist prescribing of eligible urinary drugs in females increased by 33.3 per 1000 person-years (95% CI 30.8 to 36.6) while physician prescribing decreased by 23.3 (95% CI –32.2 to –15.3), leading to a modest net increase of 10.1 (95% CI 0.0 to 18.7). Pharmacist prescribing of doxycycline was offset by decreased physician prescribing, resulting in no change (0.0, 95% CI –1.0 to 0.9). Pharmacist prescribing for other antibiotics was low over the study timeframe, while physician prescribing increased, which was driven by increased prescribing of penicillins and macrolides.

There was a clear increase in pharmacist prescribing for eligible drugs in the eligible population post-policy implementation. Pharmacists in Ontario appear to be prescribing within policy limits for uncomplicated UTIs and LD prophylaxis.

Falls are highly prevalent among individuals with dementia, largely due to the cognitive and physical impairments associated with the condition. Understanding the barriers and challenges to fall prevention in community-dwelling individuals with dementia is essential for developing tailored strategies that address their unique risks. Despite the existing evidence on fall prevention in older adults, few reviews specifically examine the obstacles faced by persons with dementia and their caregivers in community settings. This scoping review, therefore, aims to map the barriers and challenges to preventing falls among community-dwelling individuals with dementia.

This review will follow Arksey and O’Malley’s five-stage framework and be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Extension for Scoping Reviews checklist. Six electronic databases (PsycINFO, PubMed, Web of Science, Cumulative Index to Nursing and Allied Health Literature, Scopus and Embase) will be searched for relevant studies published between 2014 and 2024. Grey literature sources, including dissertations and conference proceedings, will also be included. Data will be charted and synthesised thematically to provide an overview of barriers and contextual factors influencing fall prevention. The study commenced in August 2025 and is expected to be completed by February 2026.

As this review involves the analysis of existing literature, ethical approval is not required. Findings will be disseminated through peer-reviewed publications, conference presentations and summaries tailored for healthcare providers and caregiver groups.

The protocol is registered with the Open Science Framework: https://osf.io/gnw47/(dataset).

Retinal neurodegeneration has recently been shown to occur in tandem with neurodegenerative disease. In the expectation that disease-modifying treatments for Alzheimer’s disease (AD) and Parkinson’s disease (PD) will soon become available, it will be important to have clinically useful biomarkers for neurodegenerative disease subtyping to guide early diagnosis, inform on prognosis and stratify subgroups for treatment. Understanding differences in detectable retina changes in individuals with different neurodegenerative disease subtypes is therefore fundamental. The emerging field of oculomics posits that systemic and neurodegenerative disease can be characterised using detectable ocular biomarkers within retinal diagnostics. The aim of this review is to compare the performance of common retinal imaging modalities in neurodegenerative disease detection and subtyping.

This protocol has been reported in accordance with the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines. A comprehensive literature search will be conducted in PubMed, Web of Science and Scopus. Eligible studies will have reported using retinal diagnostic tools defined as optical coherence tomography (OCT), OCT angiography (OCTA), colour fundus photography (CFP) and electroretinography (ERG) in individuals with neurodegenerative diseases, including AD, PD, dementia with Lewy bodies, frontotemporal dementia, vascular dementia and mild cognitive impairment. There will be no time restrictions placed in these searches. Studies not written in English, not peer-reviewed and grey literature will be excluded. Screening for eligible studies and data extraction will be conducted by two independent reviewers, using predefined inclusion criteria. Any disagreements between the reviewers will be settled by discussion, and if required, third senior reviewer arbitration. The systematic review primary outcome is the performance of retinal diagnostics, namely OCT, OCTA, CFP and ERG in the detection and subtyping of aforementioned neurodegenerative diseases. The secondary outcome is to evaluate the association between changes in retinal diagnostic features (eg, retinal layer thicknesses) and neurodegenerative disease subtypes. The quality of the included studies will be assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluations) tool. A narrative synthesis approach will be used to analyse the results, with meta-analysis performed if there is sufficient data.

Ethical approval for this manuscript is not required, as this is a protocol for a systematic review and therefore no data are to be collected. Findings for this systematic review will be disseminated as a peer-reviewed publication and presentations at national and international symposiums including International Lewy Body Dementia Conference, International Congress of Parkinson’s Disease and Movement Disorders, The Association for Research in Vision and Ophthalmology.

CRD42023434024.

Oral health research provides evidence for policy and practice, yet no study has comprehensively mapped the scope of oral health research in Malaysia. The COVID-19 pandemic has also created a great impact on oral healthcare in Malaysia, including the dental care delivery. Additionally, there is a notable lack of research focusing on oral health during and after the COVID-19 pandemic. Therefore, this scoping review will aim to map the landscape of oral health research conducted in Malaysia and identify key topics, study designs, populations studied and gaps in the literature, in order to inform future research priorities and policy, particularly in the post-COVID-19 era.

The methodology draws on Arksey and O’Malleys’ seminal framework for the scoping review and will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Review (PRISMA-ScR) guidelines. We will search five major electronic databases—PubMed, Scopus, ProQuest, Cochrane and Web of Science—as well as selected grey literature sources (eg, theses, dissertations and conference proceedings) for studies published in English from January 2014 to December 2024. Studies of any design related to oral health in Malaysia will be included. Two reviewers will be performing title and abstract screening, in which they will be working independently. The included publication will undergo a full-text review, and references cited in these studies will be examined following the inclusion criteria. The PRISMA-ScR flow diagram will be used as a guide throughout the process. Data will be extracted, analysed and charted according to key categories identified in the included publications. A narrative synthesis and descriptive statistics will be presented.

The results of this scoping review will illustrate an overview and provide a better understanding regarding the oral health research in the Malaysian context; whether research has already been conducted, is currently ongoing and is still needed; and which areas should be prioritised for future investigation. As this review will use publicly available literature, formal ethics approval will not be required. The findings will be submitted for publication in an open-access peer-reviewed journal, presented at national and regional conferences and shared with Malaysian dental professional bodies and relevant stakeholders.

The protocol of this scoping review is registered with the Open Science Framework and is available at osf.io/hjq6m.

Improving outcomes from sepsis in children is a WHO Global Health Priority, yet mortality from sepsis remains high, particularly in low- and middle-income countries (LMICs). This database from children with community-acquired childhood sepsis in LMICs and some high-income countries will allow analysis of the burden of disease, including incidence, severity and outcomes. Understanding these aspects of sepsis care is fundamental for the design and conduct of future international interventional trials to improve childhood sepsis outcomes.

This multicountry retrospective observational study will include children up to 18 years of age presenting to emergency departments with suspected sepsis, defined as admission to hospital for treatment with intravenous antibiotics plus (1) a provisional diagnosis of sepsis and/or (2) treatment for suspected sepsis (operationalised as the administration of one or more fluid bolus to treat impaired perfusion or vasoactive infusion). Presenting characteristics, management and outcomes will be collected. These will include vital signs, serum biomarkers, intravenous fluid administration for the first 24 hours of hospitalisation, organ support therapies delivered, antimicrobial use, microbiological diagnoses, hospital and intensive care unit length of stay, and mortality censored at hospital discharge or 30 days from enrolment (whichever occurs first).

Central ethics approval was received from the Royal Children’s Hospital of Melbourne, Australia Human Research Ethics Committee (HREC/100648/RCHM-2023). Each international site will be required to obtain local Institutional Research Ethics Board approval. The findings will be disseminated in peer-reviewed journals, at academic conferences and through lay media. A cleaned study database and individual site-level data will be made available to site investigators upon completion of the study.

This study was registered with the Australian and New Zealand Clinical Trials Registry on 23 January 2024 prior to commencement of recruitment (ACTRN12624000052538).

Tobacco use accounts for approximately 1.35 million deaths annually in India, disproportionately affecting low-income individuals, men, rural residents, those without formal education and groups of low socioeconomic status (SES). Despite progress in tobacco control, scalable, low-cost solutions, such as brief advice interventions, are needed. This study explored priority implementation determinants for adapting an evidence-based brief advice/counselling intervention for high-reach, low-resource settings in Mumbai, India. The focal settings (health-focused and tuberculosis-focused non-governmental organisations (Health NGOs and TB NGOs) and dental clinics) served low-SES populations.

Mumbai-based and US-based team members conducted a qualitative study employing semistructured interviews to gather data from four groups connected to Health and TB NGOs and dental clinics: (1) 15 patients, (2) 33 practitioners, (3) nine practice leaders and (4) three policymakers. We used a team-based, critical, reflexive thematic analysis approach to analysis, grounded in the Exploration, Preparation, Implementation and Sustainment framework. We managed data with Nvivo software.

Participants were supportive but highlighted diverse challenges and supports required for implementing the intervention in these diverse settings. First, many noted that societal constraints such as economic insecurity and cultural factors were expected to limit tobacco control efforts for low-SES populations. Second, setting-specific intervention adaptations were identified as necessary to support integration and ensure access to support for all patients. Various participant groups highlighted different adaptation areas. For example, patients noted that tobacco was part of their routines and social lives, practitioners emphasised the need to design implementation plans that support integration alongside existing needs, and policymakers highlighted the need for uniform implementation strategies.

Adapting brief advice/counselling interventions for Health NGOs, TB NGOs and dental clinics in Mumbai will require strategic communication to support buy-in, thoughtful workflow integration and changes to funding and support mechanisms for organisations so meaningful reductions in tobacco use can be achieved among low-SES groups. In other words, there is a need to adapt both the intervention and the implementing system to allow for brief advice/counselling to contribute to broader tobacco control efforts.

R01 CA230355.

Glaucoma is a chronic disease characterised by progressive visual field defects. It is the most common cause of irreversible blindness and is associated with a decrease in quality of life.1 Most studies in literature look at specific challenges faced by patients with glaucoma like adherence to medications, driving or depression.2–4 There is a paucity of...

The primary objective of this study is to investigate the perceived need and attitudinal perspectives regarding menstrual leave policies among young women in rural South India. The secondary objective was to determine the socio-demographic, menstrual and workplace-related factors associated with attitudes towards menstrual leave among young women.

An analytical cross-sectional study was performed from May 2023 to August 2023.

In a rural district of Tamil Nadu, South India.

The study encompassed 955 young female students above 18 years of age enrolled in educational institutions in a rural district of Tamil Nadu, India. Participants were pursuing diverse professional programmes including medical, dental, allied health sciences, pharmacy and engineering courses.

The primary outcomes included assessment of basic menstrual characteristics (age of menarche, regularity, product usage and pain experiences), pain evaluation using the WaLIDD scale (which measured working ability, anatomical pain location, pain intensity via Wong Baker scale and pain duration) and attitude assessment through a 10-dimension Likert scale. The attitude assessment explored both supportive factors (pain management, environmental considerations, medical leave allocation, menstruation normalisation and performance impact) and potential concerns (medicalisation, perceptions of fragility, stigma, disclosure issues and abnormal leave usage). Secondary outcome measures encompassed the analysis of factors influencing these attitudes, followed by a multivariable linear regression model to identify significant predictors.

Among 955 female students (mean age 19.56±1.33 years), the majority supported menstrual leave for maintaining hygiene (82.3%) and managing dysmenorrhoea (75.8%). A substantial proportion (64.4%) viewed it as a means of normalising menstruation discourse, while 61.6% believed it could enhance workplace performance. However, concerns existed about medicalising menstruation (47.9%) and reinforcing gender stereotypes (43.4%). Multivariate analysis revealed that medical students (B=0.67, 95% CI: 1.34 to 2.00), those with graduate-educated fathers (B=1.64, 95% CI: 0.31 to 2.97), earlier age at menarche (B=–0.23, 95% CI: –0.45 to –0.01) and participants reporting menstrual interference with daily activities (B=0.96, 95% CI: 0.02 to 0.89) held significantly more positive attitudes.

While young women generally support menstrual leave policies, particularly for hygiene and pain management, there are significant concerns about workplace stigmatisation and gender stereotyping. Educational background, parental education and personal menstrual experiences significantly influence attitudes toward menstrual leave. These findings suggest the need for carefully structured menstrual leave policies that balance biological needs with workplace/student place equality concerns.

Structural MRI of the brain is routinely performed on patients referred to memory clinics; however, resulting radiology reports, including volumetric assessments, are conventionally stored as unstructured free text. We sought to use natural language processing (NLP) to extract text relating to intracranial volumetric assessment from brain MRI text reports to enhance routine data availability for research purposes.

Electronic records from a large mental healthcare provider serving a geographic catchment of 1.3 million residents in four boroughs of south London, UK.

A corpus of 4007 de-identified brain MRI reports from patients referred to memory assessment services. An NLP algorithm was developed, using a span categorisation approach, to extract six binary (presence/absence) categories from the text reports: (i) global volume loss, (ii) hippocampal/medial temporal lobe volume loss and (iii) other lobar/regional volume loss. Distributions of these categories were evaluated.

The overall F1 score for the six categories was 0.89 (precision 0.92, recall 0.86), with the following precision/recall for each category: presence of global volume loss 0.95/0.95, absence of global volume loss 0.94/0.77, presence of regional volume loss 0.80/0.58, absence of regional volume loss 0.91/0.93, presence of hippocampal volume loss 0.90/0.88, and absence of hippocampal volume loss 0.94/0.92.

These results support the feasibility and accuracy of using NLP techniques to extract volumetric assessments from radiology reports, and the potential for automated generation of novel meta-data from dementia assessments in electronic health records.

Understanding maternal perceptions of the quality and safety of care serves as a crucial management tool for the planning and enhancement of health interventions. In Iran, where cultural norms emphasise mothers’ central role in caregiving and healthcare resources are often limited, incorporating their perspectives into nursing care strategies is essential. This study aimed to assess the perception of key nursing safety practices among Iranian mothers of children with leukaemia undergoing their first chemotherapy course.

A longitudinal study.

Oncology wards of hospitals affiliated with Tabriz University of Medical Sciences.

Mothers of children with leukaemia.

The mean perception score increased from 2.75 (out of 4) at baseline to 2.99 by week 4. The largest increases in perception were observed in patient identification and hand hygiene, with mean differences of 0.41 and 0.38, respectively. A significant increase in overall perception and subscales was observed (p

Actively involving mothers in the care process enhances their perceptions of safety and quality during hospitalisation. Supportive and educational interventions are needed to further improve the safety and quality of nursing care.

Injury is a major cause of death in Rwanda, with many deaths occurring before hospital admission. Timely transport of injured patients to appropriate hospitals is crucial, ideally within an hour for severely injured patients. However, delays in reaching treatment facilities are common, with ambulance services using inefficient mobile phone communication. This project aims to evaluate the effectiveness and implementation of an innovative electronic communication platform (912Rwanda).

The study will be conducted through the public ambulance service, Service d’Aide Médicale d’Urgence (SAMU), and receiving health facilities in Kigali city and Musanze district in Rwanda. The 912Rwanda intervention will be rolled out in the two locations at different times. The primary effectiveness outcome is the time from ambulance deployment to patient arrival at the health facility. Secondary effectiveness outcomes include disaggregated times of the primary outcome and clinical outcomes, such as length of stay and requirement for intensive care. These outcomes will be evaluated using an interrupted time series analysis, accounting for non-homogeneous variances, auto-regressive errors and non-linear trends where appropriate. Implementation outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) Qualitative Evaluation for Systematic Translation (QuEST) framework. Cost-effectiveness will be evaluated using a cost-consequence analysis with consequences as determined by the interrupted time series analysis.

Ethical approval was obtained from the Rwanda National Research Ethics Committee (Ref No: 99/RNEC/2023). Dissemination will occur through open-access peer-reviewed publications, relevant national and international conferences.

ISRCTN97674565.

To assess the implementation feasibility and acceptability of a structured digital psychosocial communication tool (DIALOG+) to strengthen the quality of person-centric care in psychiatric settings within Pakistan and India.

A hybrid inductive and thematic qualitative analysis using individual interviews (IDIs) and focus group discussions (FGDs).

Two psychiatric hospitals (Karwan-e-Hayat and Jinnah Postgraduate Medical Centre) in Karachi, Pakistan and one psychiatric care organisation (Schizophrenia Research Foundation) in Chennai, India

Interviews were conducted with 8 mental health clinicians and 40 patients who completed the DIALOG+ pilot as well as wider stakeholders, that is, 12 mental health clinical providers, 15 caregivers of people with psychosis and 13 mental health experts.

A technology-assisted communication tool (DIALOG+) to structure routine meetings and inform care planning, consisting of monthly sessions over a period of 3 months. The intervention comprises a self-reported assessment of patient satisfaction and quality of life on eight holistic life domains and three treatment domains, followed by a four-step solution-focused approach to address the concerns raised in chosen domains for help.

Key insights for the implementation feasibility and acceptability of DIALOG+ were assessed qualitatively using inductive thematic analysis of 22 IDIs and 8 FGDs with 54 individuals.

Clinicians and patients ascribed value to the efficiency and structure that DIALOG+ introduced to consultations but agreed it was challenging to adopt in busy outpatient settings. Appointment systems and selective criteria for who is offered DIALOG+ were recommended to better manage workload. Caregiver involvement in DIALOG+ delivery was strongly emphasised by family members, along with pictorial representation and relevant life domains by patients to enhance the acceptability of the DIALOG+ approach.

Findings highlight that the feasibility of implementing DIALOG+ in psychiatric care is closely tied to strategies that address clinician workload. Promoting institutional ownership in strengthening resource allocation is essential to reduce the burden on mental health professionals in order to enable them to provide more patient-centric and holistic care for people with psychosis. Further research is required to explore the appropriateness of including caregivers in DIALOG+ delivery to adapt to communal cultural attitudes in South Asia.

Rare diseases (RD) are collectively common and often genetic. Families value and can benefit from precise molecular diagnoses. Prolonged diagnostic odysseys exacerbate the burden of RD on patients, families and the healthcare system. Genome sequencing (GS) is a near-comprehensive test for genetic RD, but existing care models—where consultation with a medical geneticist is a prerequisite for testing—predate GS and may limit access or delay diagnosis. Evidence is needed to guide the optimal positioning of GS in care pathways. While initiating GS prior to geneticist consultation has been trialled in acute care settings, there are no data to inform the utility of this approach in outpatient care, where most patients with RD seek genetics services. We aim to evaluate the diagnostic yield, time to diagnosis, clinical and personal utility and incremental cost-effectiveness of GS initiated at the time of referral triage (pre-geneticist evaluation) compared with standard of care.

200 paediatric patients referred to one of two large genetics centres in Ontario, Canada, for suspected genetic RD will be randomised into a 1:1 ratio to the intervention (GS first) or standard of care (geneticist first) arm. An unblinded, permuted block randomisation design will be used, stratified within each recruitment site by phenotype and prior genetic testing. The primary outcome measure is time to genetic diagnosis or to cessation of active follow-up. Survival analysis will be used to analyse time-to-event data. Additional measures will include patient-reported and family-reported measures of satisfaction, understanding and perceived test utility, clinician-reported measures of perceived test utility and management impact, and healthcare system utilisation and costs.

This study was approved by Clinical Trials Ontario. Results will be disseminated, at minimum, via peer-reviewed journals, professional conferences and internal reports to funding bodies. Efforts will be made to share aggregated study results with participants and their families.

NCT06935019.

Time-lapse imaging (TLI) systems for embryo incubation and assessment are hypothesised to improve the success rates of in vitro fertilisation (IVF) treatment by providing undisturbed culture conditions for embryos and/or providing more information on embryo development (morphokinetic parameters) to improve predictive accuracy for embryo selection. Despite numerous aggregate meta-analyses showing uncertainty of benefit, IVF clinics globally continue to invest significant resources into this technology with little translation of evidence into guidelines or policy frameworks. This may be attributed to heterogeneity in participant populations and/or variations in the use of TLI, as highlighted in the aggregate meta-analyses.

Our research proposal for evidence synthesis using individual participant data meta-analysis will provide greater power than aggregate meta-analysis to detect differential treatment effects for effectiveness (live birth, clinical pregnancy) and safety (pregnancy loss, multiple births, congenital malformations) outcomes across three comparisons (overall effect, undisturbed culture and morphokinetic parameters). We will also analyse if there are specific subgroups of women who may benefit from the intervention and if variations in use of the intervention show any benefits. We have incorporated the results of the literature search used for the latest Cochrane review (7 January 2019) into this review and will include all the trials included therein. We will further update the literature search to include new evidence by searching the electronic databases MEDLINE, EMBASE, CINAHL and CENTRAL from 07/01/2019 to date, outcomes for all ongoing trials reported in the 2019 Cochrane review, trial registers for newer ongoing/completed trials and the citation lists of all the newly identified trials for any relevant references. The search strategy will include a combination of subject headings and text words relating to or describing the participants and the intervention, with no language restrictions. Two authors will independently screen the titles and abstracts, and full text of articles retrieved from the search, to finalise a list of trials suitable for inclusion in the review. We will include randomised controlled trials that assess TLI systems for either undisturbed culture and/or use of morphokinetic parameters for embryo selection in women having IVF/ICSI treatment using their own oocytes.

Ethical approval is not required for this study. We plan to disseminate the findings of the research to all stakeholders, including the National Institute for Health and Care Excellence and other international guideline development groups, through publication in peer-reviewed journals, presentation at conferences, newsletters, meetings and websites of the funders, fertility charities and patient support groups.

CRD42024564332.

Using the community-based participatory research (CBPR) methodology, sustained peer group treatment has effectively improved medication adherence. Although many studies investigate the effectiveness of peer group therapy, there is a lack of evidence addressing the cost-effectiveness of CBPR models in low- and middle-income countries. This protocol outlines the methods for the economic evaluation of the PArticipatory Research model for medicaTIon adherenCe In People with diAbetes and hyperTEnsion (PARTICIPATE) trial to determine whether the CBPR approach to enhance medication adherence among patients with diabetes and/or hypertension is cost-effective in India.

A within-trial cost-effectiveness analysis (CEA) from a societal perspective will be conducted alongside a multicentre cluster randomised controlled trial to identify, measure and evaluate the key resource and outcome impacts of a CBPR model compared with usual care aimed at improving medication adherence in adult rural Indian patients with diabetes and/or hypertension. The CEA will provide results in terms of the cost per improvement in medication adherence score, and a cost-utility analysis (CUA) will express the findings as the cost per disability-adjusted life year (DALY) or quality-adjusted life year (QALY) gained. Intervention costs and effects will be projected for the population of Indian adults with diabetes and/or hypertension who are on medication, analysed over the cohort’s lifetime. Results from the modelled CUA will detail incremental costs, costs per death averted and costs per DALY averted/QALY gained for the interventions relative to the comparator. Incremental cost-effectiveness ratios will be computed by dividing the cost difference between the intervention and comparator by the difference in benefits. Health economic evaluation methods, including a lifetime horizon, a 3% discount rate for costs and benefits and a societal perspective, will be followed. The effects of sampling uncertainty on estimated incremental costs and effectiveness parameters, as well as the influence of methodological assumptions (such as the discount rate and study perspective), will be examined through both deterministic and probabilistic sensitivity analyses. Relevant differences in costs, outcomes or cost-effectiveness disparities among subgroups of patients with varying baseline characteristics will also be reported. Results will be illustrated using cost-effectiveness acceptability curves across a range of willingness-to-pay thresholds. Modelled CUA will broaden the target population and time frame to offer decision-makers insights into the cost-effectiveness of the CBPR approach for enhancing medication adherence. Furthermore, a return on investment analysis will be performed to express benefits in monetary terms relative to investments made, allowing for a comprehensive expression of both costs and the full spectrum of intervention benefits in monetary units.

The Institutional Ethics Committee of Sri Aurobindo Medical College and PGI, Indore, provided ethics approval. The results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal and disseminated through reports to Indian Council of Medical Research and conference presentations.

Clinical Trial Registry of India (CTRI) CTRI/2024/01/061939.

The purpose of this study was to analyse the speech-language pathology (SLP) literature from 2012 to 2022 and evaluate authorship trends and factors associated with gender disparities.

Authorship across journals published by the American Speech-Language-Hearing Association (ASHA) was evaluated. Outcomes collected from each article included the gender of the first and senior authors, author department affiliations, study type, reported funding source and the country of origin. Three sets of linear regression models were explored to determine the probability of male first authorship, of male senior authorship, and of a study being funded.

A total of 2754 articles were identified for inclusion. The majority of the literature was authored by females, with 77% of first authors and 68% of senior authors being female. Studies with a male senior author were shown to be 4.05–4.67 times more likely to have a male first author than with a female senior author. Male senior authors were over-represented relative to their proportion of ASHA membership compared with female senior authors. Male authorship was associated with certain subtopics, including voice, stuttering and motor speech. Funding probability decreased for all authors regardless of gender between 2012 and 2022.

Implicit gender bias and societal gender stereotypes lead to a greater number of women in the field of SLP; the same biases and stereotypes often limit the research productivity and academic leadership potential of women in the field. Addressing these biases and stereotypes is vital to move towards gender equity in the field.