In cluster randomised trials (CRT), groups (rather than individuals) are randomised to intervention and control conditions. Since the publication of the Ottawa Statement on the Ethical Design and Conduct of CRTs, the accurate identification of research participants has continued to challenge researchers and research ethics committees.

In this article, we focus on CRTs involving healthcare providers and provide a practical framework for applying Ottawa Statement criteria for identifying research participants. We illustrate key lessons with example CRTs.

Study procedures should be analysed in relation to the study objective. A study intervention confers research participant status on healthcare providers if the study objective is to evaluate its effect and it is delivered to or targeted at healthcare providers. A data collection procedure confers research participant status on healthcare providers if it informs a study outcome used to achieve the study objective and it involves interactions between researchers and healthcare providers to collect their data, or the collection of healthcare providers’ identifiable private information.

In CRTs, healthcare providers may be research participants because of study interventions, data collection procedures, or both; conversely, they may simply be research collaborators. Some study interventions confer research participant status on both healthcare providers and patients. Collecting data on healthcare provider behaviour may confer research participant status on healthcare providers.

Accurately identifying research participants in CRTs is essential to their ethical conduct. When healthcare providers are research participants, their rights and welfare should be protected in accordance with research ethics guidelines.

Exercise therapy is the most recommended treatment for chronic low back pain (LBP), with evidence supporting modest effects, likely due to the heterogeneity of patient presentations. Evidence suggests that matching individuals to the most appropriate exercise type could improve outcomes. Systematic reviews also emphasise that effective exercise interventions should be patient centred, target paraspinal muscle health and be of sufficient duration. This study addresses these gaps using a targeted care approach to identify a homogenous sample that is more likely to respond to our interventions. The inclusion of a sample with predominant nociceptive pain profile will be performed with the integration of the Pain and Disability Drivers Management Model (PDDM) and the Lumbar Spine Instability Questionnaire (LSIQ). The primary aim of this two-arm randomised controlled trial is to compare the effectiveness of motor control plus isolated lumbar extension exercises (MC+ILEX, arm 1) to free-weight resistance training (arm 2) in reducing LBP-related disability. Secondary aims include examining whether changes in multifidus composition mediate disability improvements comparing intervention effects on muscle size and quality, strength, mobility, pain, quality of life, sleep, physical activity and satisfaction; exploring baseline LSIQ scores and sex/gender as moderators of treatment response; and investigating participants’ perceptions and experiences of exercise therapy.

A total of 106 participants will be recruited through primary and secondary care and randomised (1:1) to receive either MC+ILEX or free-weight resistance training. Both groups will complete 48 exercise sessions over 16 weeks. The primary outcome will be disability at 16 weeks, measured by the Oswestry Disability Index. Secondary outcomes include multifidus muscle composition and size, lumbar and gluteal muscle strength, hip range of motion, pain, physical and mental function, satisfaction and recovery, health-related quality of life, sleep quality and physical activity levels. Linear mixed-effects models will be used to assess primary and secondary outcomes. Regression analyses will explore whether baseline LSIQ scores moderate treatment effects on multifidus composition and other outcomes. A subsample of participants will undergo semistructured interviews before and after the intervention to explore their illness perceptions, illness mindsets, perceptions of exercise therapy, as well as their experiences and satisfaction with the two exercise interventions. Reflexive thematic analysis will be used to analyse qualitative data.

This study received ethics approval from the Central Ethics Research Committee of the Quebec Minister of Health and Social Services (CCER-25-26-14). Results will be submitted to peer-reviewed journals and scientific meetings.

ISRCTN14864451.

While almost half of older adults admitted to hospital are prescribed potentially inappropriate medicines, less than 1% have a medicine proactively deprescribed during admission in the UK. The CompreHensive geriAtRician-led MEdication Review (CHARMER) intervention is designed to address geriatricians’ and pharmacists’ barriers and enablers to deprescribing. The CHARMER definitive trial will evaluate effectiveness, cost-effectiveness and safety.

A stepped-wedge cluster randomised controlled trial will be conducted in 20 hospitals in England, with four hospitals in reserve. All hospitals will collect baseline data. Every 3 months, five hospitals will be randomised to receive the intervention. The intervention, implemented by a local project manager, comprises a hospital action plan to set deprescribing as an organisational goal; workshops for pharmacists and geriatricians to change beliefs about deprescribing; weekly briefings between geriatricians and pharmacists to discuss opportunities for deprescribing; benchmarking reports to compare deprescribing performance across participating hospitals. With an average of 200 patients admitted and discharged during each step, the study will have 89.5% power at 5% significance level and intra-class correlation coefficient of 0.05 to detect a 3% difference in 90-day re-admission rate from 16.7% versus 13.7%. Anonymised routinely collected data, including readmissions, will be obtained for all patients admitted during the study period. Enhanced data collection periods of 1 month during control and intervention periods will be used to recruit patients and data for secondary outcomes and process evaluation.

A stepped-wedge design enabled a smaller number of hospitals and patients to be included than a traditional cluster-randomised design. The complexity of intervention implementation necessitated a project manager in addition to the principal investigator responsible for trial conduct. Using routinely collected data for the primary outcome measure should ensure that the trial has sufficient power on completion. Planned enhanced data collection for short periods of time improves trial efficiency.

ISRCTN13248281.

To establish consensus definitions for non-visually impairing eye conditions (NVICs) and their methods of assessments to provide standards for use in population-based eye surveys.

A literature review of NVICs in sub-Saharan Africa, a questionnaire of inquiry based on the literature review developed by an expert panel and a modified Delphi exercise with three iterative rounds with eye health experts.

Eye health academia and community eye health in Nigeria.

Nigerian ophthalmologists, including subspecialists experienced in population-based eye health surveys.

Definitions and statements where at least 70% of the respondents agreed or strongly agreed.

Forty-two ophthalmologists practising in Nigeria with experience in conducting population-based eye health surveys were invited to take part in the Delphi exercise. There were three rounds with response rates of 39/42 (92.9%) in round 1, (94.9%) in round 2 and 100% in round 3. Consensus for NVICs to be included in population-based eye surveys, their definitions and methods for assessment was reached by the third round.

We propose case definitions for NVICs to be assessed in population-based eye surveys through a modified Delphi approach with an expert panel of ophthalmologists from across Nigeria. These case definitions will allow for standardisation of NVICs in population-based eye surveys to assess the prevalence and magnitude of the different types of NVICs for planning purposes. Further studies are needed to validate these case definitions and inform their evolution.

Concentration of care and collaborations between hospitals increasingly reorganise oncological care into Comprehensive Cancer Networks (CCNs), aiming to improve care outcomes and reduce costs. This study aims to evaluate the effect of four CCNs on healthcare cost and outcomes for patients with colon or pancreatic cancer.

We performed a retrospective cohort study based on claims data in the Netherlands. Data included patient characteristics, health insurance claims and healthcare activities. All costs were indexed to Euro 2023. We performed propensity score matching per CCN and applied regression models with a difference-in-difference design, adjusting for non-linear trends before the start of a CCN.

The study was conducted within the Dutch healthcare system, analysing claims data representative of hospital-based cancer care.

A total of 92 309 patients with colon cancer and 25 630 patients with pancreatic cancer were included. Patients were identified through health insurance claims between January 2013 and June 2021.

Implementation of four CCNs, which included structured collaboration between healthcare organisations. Follow-up duration was 2 years post-diagnosis.

Primary outcomes included 2-year oncological healthcare costs and 2-year mortality rate. Secondary outcomes involved care process indicators: referral rates and double diagnostics (an identical diagnostic activity performed within 4 weeks after referral to a secondary hospital).

For colon cancer, one CCN showed a significant decrease in 2-year oncological costs (–1899). One CCN showed a significant decrease in referrals (–3.6%) and one a significant increase (+4.4%). No significant effect on 2-year mortality and double diagnostic activities was found. For pancreatic cancer, one CCN showed a significant decrease in 2-year oncological costs (–3747) and one CCN showed a significant increase in double diagnostic activities (+8.6%). No significant effect on referrals and 2-year mortality was found.

CCNs do not consistently reduce costs or affect referral patterns or redundant diagnostics. No impact on mortality was found. Additional insights into determinants of CCN success are required before broad implementation is warranted.

Case reports (CRs) are essential in physiotherapy, yet reporting remains heterogeneous and insufficiently standardised. The 2013 CAse REport (CARE) guideline improves transparency but lacks physiotherapy-specific detail. This study aimed to develop a consensus-driven extension of the CARE reporting guideline to support structured reporting of physiotherapy CRs, encompassing physiotherapy-specific assessments and interventions.

An e-Delphi consensus process study following the ACcurate COnsensus Reporting Document (ACCORD) guidelines.

Online.

Forty-four international experts in physiotherapy practice, research and education, along with six core committee members.

Experts objectively scored items for relevance (5-point Likert scale) and provided open-ended responses for each item of the drafts. Scores and responses were analysed to facilitate iterative refinement of the Physiotherapy CAse REport (PhyCARE) reporting guidelines. Consensus was predetermined at over 70% agreement.

Round 1 had the majority of items achieving ≥70% agreement, except two items that did not meet the threshold were revised and replaced with an alternative. Five new items addressing physiotherapy-specific reporting needs were added, and 10 items were relocated. In round 2, all 35 items across 13 domains achieved 84%–100% agreement. The nomenclature of one domain was revised to ‘Outcomes and Follow-up’. Following two e-Delphi rounds, consensus was achieved, and suggestions from online meeting, piloting led to item rephrasing, after which the PhyCARE guidelines were finalised.

The PhyCARE guidelines have the potential to provide a physiotherapy-specific extension of CARE to support structured, transparent and reproducible reporting of physiotherapy CRs.

Compared with other high-income countries, the USA continues to have the highest rates of pregnancy-related and associated mortality and morbidity (PRAMM), particularly in rural areas and among non-Hispanic black pregnancies. Over 80% of pregnancy-related deaths are preventable; however, the intensity of existing interventions has proven difficult to broadly disseminate. Technology offers the potential to address such barriers. This study will develop a multilevel digital intervention to reduce PRAMM and evaluate its effects using a site-randomised trial.

The Michigan Healthy Mom (MI MOM) intervention will be developed using a community-partnered approach and will seek to address PRAMM risks at four distinct levels: individual, support system, provider and community. Pregnant participants and up to three members of their personal support system will receive an initial brief interactive session through a mobile web app and will thereafter receive a series of text messages with links to extended content. Healthcare providers will receive biweekly text messages and/or flyers distributed in clinic staff areas, and community health workers—who can facilitate access to local services—will be available via secure live chat text access. MI MOM effects will be evaluated using a cluster-randomised trial in 10 antenatal care clinics throughout Michigan (N=500 pregnant participants aged 18+ years receiving Medicaid). We will compare intervention and control arms on two coprimary outcomes: total PRAMM through 1 year post partum as measured using a universally collected linked dataset of Medicaid claims and vital records and an index of PRAMM risk factors directly targeted by MI MOM.

The Michigan State University Institutional Review Board has provided ethical approval (STUDY00011005). Results will be disseminated via presentations at academic conferences and community forums, as well as publications in peer-reviewed journals.

NCT07213284.

The Veterans Health Administration (VA) integrated mental and physical health services to better detect and treat depression. Primary care nurses conduct screening annually. Clinicians, including Primary Care Mental Health Integration (PCMHI) specialists, follow-up as needed for treatment. Depression detection and management processes are complex, involve multilevel stakeholders, and are subject to significant disruption from COVID-19 and from the resulting expansion of telehealth, aiming to preserve care access. This study aimed to examine whether the COVID-19 pandemic worsened depression-related care quality and/or patient outcomes (eg, suicide).

Given hypothesised care disruption (lowered care quality) during COVID-19, we will first assess the VA population’s trajectory from a new positive depression (and suicide risk) screen to appropriate treatment (ie, medication, therapy) in the Fiscal Year 2019–2323. We will also examine the changing mix of virtual and in-person depression care delivered. Second, we will use interrupted time series analyses to explore the extent to which psychiatric emergency visits and hospitalisations may be mitigated by clinician detection of depression. As well as compare mental health-related mortality rates between patients detected and not detected to have depression. Subanalyses will reveal where (eg, clinics with low PCMHI access) and for whom (eg, minorities) detection does not systematically occur, and downstream negative sequelae, to guide future intervention. Finally, we will interview 40 veterans, half of whom were detected and half not detected to have depression and 40 VA primary care and PCMHI providers about changes brought on by the pandemic and the expansion of virtual care across three VA facilities. In addition to contextualising disrupted care findings, qualitative data will help identify best practices on patient-to-provider and provider-to-provider interactions in hybrid in-person/telehealth depression care models.

Ethics approval was granted by the VA Greater Los Angeles Healthcare System Institutional Review Board. Alongside journal publications, dissemination activities include briefings to our policy and operational partners, and presentations to clinical, research and policy-oriented audiences.

To evaluate the cost-effectiveness of implementing a penicillin allergy assessment pathway (PAAP) versus usual care within the NHS.

A decision tree analysis over a 5-year time-period, informed by a randomised controlled trial (RCT) of PAAP and systematic review. Value of information analysis was also conducted to estimate the value of conducting a new trial.

Model inputs were informed by the ALABAMA RCT participants included in the primary analysis, 811 adults with penicillin allergy labels and recent antibiotic prescriptions, and data from published literature.

Participants in the ALABAMA trial included in the primary analysis: PAAP (n=401) and usual care (n=410).

Costs are presented in GBP (£) at 2022–2023 prices, quality-adjusted life years (QALYs), incremental cost-effectiveness ratio, incremental net monetary benefit (INMB), the probability of cost-effectiveness at the £20,000 and £30,000 per QALY threshold, and the cost effectiveness of a new follow-on trial.

PAAP had incremental costs of £–83 (probability of cost saving 47.5%) and incremental QALYs of 0.036 (probability of positive benefits 47.5%). The INMBs (probability of cost-effectiveness) were £806 (48%) and £1167 (48%) under the decision thresholds of £20,000 and £30,000 per QALY, respectively. PAAP was more cost-effective among females, people aged >65 years, and more frequent antibiotic users. A new follow-on trial involving 1267 participants was estimated to cost £2.4 million and, by reducing uncertainty in the evidence, would avoid £19.6 million in costs of incorrect management decisions for eligible patients over the next 10 years.

The PAAP was considered cost-effective, but significant uncertainty remained. Future trials with adequate power and longer follow-up are needed to determine the most cost-effective models for penicillin allergy testing.

ISRCTN20579216.

Early-onset chronic liver disease (CLD) and its subsequent clinical progression have systemic impact. Its trajectory coincides with critical periods of brain development. In this study, we will test the hypothesis that early-onset CLD is associated with neurodevelopmental and psychiatric symptoms and delineate their neurobiological underpinnings through multimodal neuroimaging.

This study will recruit 100 patients with biliary atresia and 50 patients with other types of early-onset CLD, aged between 6 and 30 years, under the primary care of Paediatric Liver Services at King’s College Hospital, London, UK. Cognitive performance and autism-related behaviours will be evaluated with neurodevelopmental assessments. Participants and their parents will complete questionnaires addressing neurodevelopmental and psychiatric outcomes in everyday life, and quality of life. Multimodal neuroimaging will be conducted using electroencephalography (EEG); eye-tracking; structural, functional and diffusion MRI; and magnetic resonance spectroscopy (MRS). Clinical information will be collected from patients’ medical records and bio samples. Data of 222 neurotypical controls and 307 neurodivergent controls without CLD will be pooled from the Longitudinal European Autism Project with a similar study protocol. Neurodevelopmental and psychiatric outcomes will be compared with normative values and between groups. Associations with clinical risk factors will be explored using multivariable regression. Neuroimaging markers will be compared between groups and associations with neurodevelopmental outcomes and clinical risk factors will be tested using multivariable regression. Individual deviation from normal brain development will be quantified using Bayesian modelling and will be associated with neurodevelopmental outcomes.

This study was approved by the National Health Service Health Research Authority’s ethical committee (REC reference: 22/PR/1587). Findings from this study will be published in peer-reviewed journals, presented at national and international conferences and shared with patients and their families for widespread dissemination of the results.

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

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

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

ACTRN12624000658516.

Intraoperative anaesthesia handoffs represent a risk point in the care of surgical patients. Although often necessary to prevent fatigue, improve vigilance and optimise operational efficiency, critical information can be lost, potentially leading to postoperative complications. Structured handoffs can increase the transfer of knowledge during intraoperative anaesthesia handoffs, improving their quality. We therefore propose to test the primary hypothesis that a semi-structured intraoperative anaesthesia handoff cognitive aid reduces the number of serious 30-day complications in surgical patients.

We will enrol adults having non-cardiac surgery who are scheduled to have an intraoperative anaesthesia handoff for operational reasons. We plan a cluster randomised trial (enrolling over 18 months, anticipated sample size approximately 4500 patients) that will compare the Epic Electronic Health Record intraoperative anaesthesia handoff cognitive aid to routine handoffs. Our primary outcome will be the number of serious postoperative complications within 30 days. Our secondary outcomes will be: (1) the number of minor complications; and (2) the duration of postoperative hospitalisation. Bayesian analysis with generalised linear multilevel modelling will be used to estimate the effect of structured handoffs on the primary and secondary outcomes.

This study has been approved by the local institutional review board with a waiver of informed consent. Results will be disseminated in the medical literature with de-identified data available on request.

NCT06533111.

Insomnia is a common complaint among patients with opioid use disorder (OUD) maintained on buprenorphine (BUP). However, people with OUD have historically been excluded from insomnia clinical trials, leaving clinicians without evidence-based treatment options for this patient population. Lemborexant, the Food and Drug Administration (FDA)-approved dual orexin receptor antagonist for the treatment of insomnia, was recently shown to be safe and tolerable among a sample of patients with insomnia who were maintained on BUP. We hypothesise that pharmacologically antagonising the orexin system with lemborexant may improve insomnia symptoms in individuals with OUD and also enhance BUP treatment benefits by improving performance in neurofunctional domains identified in the National Institute on Drug Abuse Phenotyping Assessment Battery.

Participants with insomnia and OUD who have been stabilised on BUP for at least 4 weeks will be randomly assigned to receive either lemborexant (n=50) or placebo (n=50) for 8 weeks. Participants will complete assessments at baseline, during the 8-week intervention, postintervention and at a 2-week follow-up. Primary outcomes are insomnia severity and impulsivity. Secondary measures include objective sleep metrics (total sleep time, sleep efficiency, sleep onset latency and wake after sleep onset) and performance in the neurofunctional domains of negative emotionality and metacognition.

The study was approved by the Virginia Commonwealth University Institutional Review Board in April 2025 (protocol number HM20031777). Data collection began in May 2025 and is expected to be completed by May 2029. The trial is conducted under FDA IND no. 154797 (FGM). The dissemination plan for the trial includes presentations at local and national conferences, submission of primary and secondary outcome manuscripts for publication in peer-reviewed journals and circulation of findings to popular media outlets, as available. Results will also be shared with interested participants and clinical collaborators upon completion of the trial.

NCT06981195.

Genomic diagnostics have accelerated therapeutic and preventative breakthroughs in oncology and cancer genetics. Despite increased access, the implementation of genomics-based care faces serious fragmentation and scalability issues due to a lack of system support. The Precision Care Initiative aims to develop a novel and scalable Precision Care Clinic (PCC). It is designed to coordinate precision medicine in oncology and streamline decision support for referring oncologists and geneticists. The PCC will enhance quality of care through multifaceted, patient-centred communication. It will also improve translational capacity by integrating team expertise in precision oncology, implementation science, clinical informatics, cancer genetics, health economics and patient-reported measures.

This programme uses a type I and type II hybrid effectiveness-implementation trial design sequentially. The complex clinical intervention is precision oncology—matching the targeted treatment or risk management strategy to the right patient, based on their genomic, cancer staging, environmental, lifestyle and biological characteristics, etc. The service intervention is the PCC, providing centralised multidisciplinary review to facilitate shared decision-making with clinicians for the provision of optimal precision oncology care for their patients. The implementation intervention is the co-designed implementation platform—applying evidence-based implementation approaches and Learning Health System principles to enhance feasibility and sustainability. All adult patients across Australia referred to the PCC (n=est. 100–150/year), and healthcare professional interest holders involved in the delivery of precision oncology services, are eligible to participate. Over the study course, phase I involves using a mixed-methods approach to inform iterative co-design and pilot testing of the first PCC with an accompanying implementation platform, and a suite of outcome measures to assess effectiveness; phase II (hybrid type I) includes the implementation of the PCC and evaluation of the outcome measures designed in phase I; phase III (hybrid type II) involves a co-design of local adaptations and testing the effectiveness of the PCC model nationally.

The study received ethical approval from the St Vincent’s Hospital Human Research Ethics Committee (2023/ETH00373). Study results will be presented at relevant conferences and published in peer-reviewed journals.

NCT06077110

This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.

A cross-sectional mixed methods online survey.

Primary care in England.

120 clinical pharmacists with experience in conducting SMRs in primary care.

Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.

These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.

Inherited retinal diseases (IRDs) are a broad range of diseases associated with abnormalities/degeneration of retinal cells. We aimed to identify the top 10 Australian research priorities for IRDs to ultimately facilitate more meaningful and potentially cost-effective research.

We conducted a James Lind Alliance priority setting partnership that involved two Australian-wide surveys and online workshops.

Australia-wide.

Individuals aged 16 years or older were eligible to participate if they had an IRD, were caregivers of an individual with an IRD or were health professionals providing care to this community.

In Survey 1, we gathered participants’ unanswered questions about IRDs. We grouped these into summary questions and undertook a literature review to verify if they were truly unanswered (ie, evidence uncertainties). In Survey 2, participants voted for the uncertainties that they considered a priority. Top-ranked uncertainties progressed for discussion and final prioritisation in two workshops.

In Survey 1, we collected 223 questions from 69 participants. We grouped these into 42 summary questions and confirmed 41 as evidence uncertainties. In Survey 2, 151 participants voted, with the 16 uncertainties progressing to final prioritisation. The top 10 priorities, set by the 24 workshop participants, represented (1) treatment/cure; (2) symptoms and disease progression; (3) psychosocial well-being and (4) health service delivery. The #1 priority was for treatment to prevent, slow down or stop vision loss, followed by the #2 priority to address the psychological impact of having an IRD.

The top 10 research priorities highlight the need for IRD research that takes a whole-person, systems approach. Collaborations to progress priorities will accelerate the translation of research into real-world benefits.

There is an absence of real-world evidence, especially from low- and middle-income countries (LMICs), on the implementation successes and challenges of COVID-19 Test and Treat (T&T) programmes. In 2022, nirmatrelvir/ritonavir was provided as standard of care for mild to moderate COVID-19 treatment in eight LMICs (Ghana, Kenya, Laos, Malawi, Nigeria, Rwanda, Uganda and Zambia). This manuscript describes a research protocol to study novel drug introduction during the COVID-19 health emergency, with implications and learnings for future pandemic preparedness. The goal of the study is to provide simultaneous programme learnings and improvements with programme rollout, to fill a gap in real-world implementation data on T&T programmes of oral antiviral treatment for COVID-19 and inform programme implementation and scale-up in other LMICs.

This multiple methods implementation research study is divided into three components to address key operational research objectives: (1) programme learnings, monitoring and evaluation; (2) patient-level programme impact; and (3) key stakeholder perspectives. Data collection will occur for a minimum of 6 months in each country up to the end of grant. Quantitative data will be analysed using descriptive statistics for each country and then aggregated across the programme countries. Stakeholder perspectives will be examined using the Consolidated Framework for Implementation Research implementation science framework and semistructured interviews.

This study was approved by the Duke University Institutional Review Board (Pro00111388). The study was also approved by the local institutional review boards in each country participating in individual-level data collection (objectives 2 and 3): Ghana, Malawi, Rwanda, Nigeria and Zambia. The study’s findings will be published in peer-reviewed journals and disseminated through dialogue events, national and international conferences and through social media.

NCT06360783.

To compare the quality and time efficiency of physician-written summaries with customised large language model (LLM)-generated medical summaries integrated into the electronic health record (EHR) in a non-English clinical environment.

Cross-sectional non-inferiority validation study.

Tertiary academic hospital.

52 physicians from 8 specialties at a large Dutch academic hospital participated, either in writing summaries (n=42) or evaluating them (n=10).

Physician writers wrote summaries of 50 patient records. LLM-generated summaries were created for the same records using an EHR-integrated LLM. An independent, blinded panel of physician evaluators compared physician-written summaries to LLM-generated summaries.

Primary outcome measures were completeness, correctness and conciseness (on a 5-point Likert scale). Secondary outcomes were preference and trust, and time to generate either the physician-written or LLM-generated summary.

The completeness and correctness of LLM-generated summaries did not differ significantly from physician-written summaries. However, LLM summaries were less concise (3.0 vs 3.5, p=0.001). Overall evaluation scores were similar (3.4 vs 3.3, p=0.373), with 57% of evaluators preferring LLM-generated summaries. Trust in both summary types was comparable, and interobserver variability showed excellent reliability (intraclass correlation coefficient 0.975). Physicians took an average of 7 min per summary, while LLMs completed the same task in just 15.7 s.

LLM-generated summaries are comparable to physician-written summaries in completeness and correctness, although slightly less concise. With a clear time-saving benefit, LLMs could help reduce clinicians’ administrative burden without compromising summary quality.

Paediatric major trauma patients with more severe injuries and physiological or biochemical abnormalities as a result of the injury are more likely to require invasive management in the form of an operation/interventional radiology (IR). Adverse psychological outcomes, such as post-traumatic stress disorder, anxiety, depression and adjustment disorder, are frequently observed in paediatric patients with major trauma. Similarly, it is recognised that children and adolescents who have invasive management are also at an increased risk of adverse psychological outcomes. However, it is not known to what extent major trauma patients requiring invasive management are at risk of adverse psychological outcomes compared with those managed conservatively. This study aims to determine whether paediatric major trauma patients who require an operation/IR have increased odds of having an adverse psychological outcome compared with those who are managed conservatively.

The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines will be used to construct this review. The databases Medline (via Ovid), Embase (via Ovid), PsycInfo (via Ebscohost) and Cinahl (via Ebscohost) will be searched from inception to February 2025. Both title and abstract screening and full-text screening will be done by two reviewers, with an adjudicating third reviewer. For randomised controlled trials, the Cochrane Risk of Bias Tool will be employed, while for non-randomised studies, the Newcastle-Ottawa Quality Assessment Scale will be used. We will assess bias using contoured funnel plots (with p set at 0.01, 0.05 and 0.10), non-parametric trim-fill analysis, leave-one-out analysis and Galbraith plotting. We will execute formal (Egger) testing for funnel plot asymmetry and also calculate prediction intervals if sufficient study N of 10 is accrued. Certainty and confidence in cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Ethical review is not required as no original data will be collected. Results will be disseminated through peer-reviewed publications and at academic conferences.

CRD42025643459.

Pharmacist prescribing has evolved to meet healthcare system needs, but the effectiveness, mechanisms and contextual factors influencing education programmes remain poorly understood. Realist approaches are fairly novel in pharmacy practice research. This realist synthesis aims to answer the question: to what extent do pharmacy prescribing education programs work (or not), for whom and under what circumstances, and why?

A realist methodology (realist synthesis) will be used to review the outcomes of programmes. Pawson’s key stages will be followed: (1) clarifying the scope; (2) determining the search strategy; (3) study selection; (4) extracting and analysing data; and (5) synthesising findings and drawing conclusions. The synthesis will follow Realist And Meta-narrative Evidence Syntheses–Evolving Standards publication guidelines. Data extracted will include the study characteristics, alongside the contexts, mechanisms and outcomes of varied pharmacy prescribing education programmes. The search strategy will include searching PubMed, Scopus, Web of Science and CINAHL Complete. An initial programme theory will use selected grey literature. Context-mechanism-outcome configurations will be identified, and recurring patterns will be synthesised to refine the initial programme theory.

Ethics approval is not required. Dissemination will be sought via peer-reviewed academic conferences and journals.

CRD420251056576.