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.

Public involvement in mental health research enhances research quality. The use of citizen science methods in mental health research has been described as a conclusion of a movement towards increased public involvement; however, this field is in its early stages of development. Our objective was to create a theory of change (ToC) for how citizen science can be used to enhance mental health research quality.

Iterative consultation with the stakeholders of an existing citizen mental health science study, that is, change for citizen science to achieve co-production at scale (C-STACS: https://www.researchintorecovery.com/research/c-stacs/)

We co-developed a ToC through an iterative consultation with C-STACS stakeholders who were (a) representatives of mental health community organisations (n=10), individuals with public involvement experience (n=2) and researchers (n=5). In keeping with established ToC practice, entities were identified, including long-term impacts, outcomes needed to create an impact, stakeholder assumptions and indicators for tracking progress.

A desired primary long-term impact of greater co-production of research was identified between researchers and members of the public, which would create a secondary impact of enhancing public capacity to engage in citizen mental health science. We proposed long-term outcomes needed to enable this impact: (1) greater co-production of research objectives and pathways between researcher and the public, (2) greater embedment of citizen mental health science into funder processes (eg, the creation of specific funding calls for citizen mental health science proposals, (3) greater clarity on the boundaries between citizen science and other participatory approaches (eg, so that there is not loss of impact due to conceptual confusion between these, (4) increased knowledge around effective frameworks to enable mass public participation and (5) greater availability of technology platforms, enabling safe and accessible engagement with citizen mental health science projects.

The proposed ToC is grounded in the C-STACS project, but intended to be broadly applicable. It allows the continued formation of a community of practice around citizen mental health science and should be reviewed, as greater knowledge is developed on how citizen mental health science creates change.

The objective of this study was to understand primary care clinician perspectives on a novel linked health data system to facilitate diabetes prevention for individuals with a history of gestational diabetes mellitus (GDM). We used the conceptual example of linking the National Gestational Diabetes Register with primary care electronic health records to understand clinicians’ views on potential implementation.

A qualitative study of semistructured interviews with primary care clinicians.

Australian primary care.

Primary care clinicians (n=14). Inclusion criteria were: general practitioners (GPs), practice nurses and/or diabetes educators working in primary care in Australia, and seeing individuals with a history of GDM; aged 18 years and over; and willing to voluntarily contribute to the project. There were no exclusion criteria.

Clinicians’ views on acceptability, feasibility and utility were characterised by realistic optimism for a linked data system to improve GP workflow and patient outcomes. Clinicians noted existing pressures on primary care and patient concerns regarding confidentiality and privacy, and that these factors should be considered in the development process. Clinicians envisaged three functions for their clinical management systems: (1) automatically updating a patient’s past history; (2) generating actionable alerts and (3) generating recall lists.

Primary care clinicians were unanimously supportive of a linked health data system to facilitate diabetes prevention. Consistent with previous studies, we identified the key clinician-related enabler as the integration into existing GP workflows to facilitate pro-active clinical care. Point-of-care tools and preventative care consultations could increase the uptake of screening and provide opportunities for patient education post partum.

In combination with effective prevention programmes, and health policy and system supports, linked health data systems could be part of the equation for type 2 diabetes prevention for individuals with a history of GDM. Larger acceptability, feasibility, co-design and implementation studies are recommended.

Gestational diabetes mellitus (GDM) is an emerging public health concern in low and middle-income countries, including Nigeria, because of the associated pregnancy complications, increased healthcare costs and long-term health sequelae among women of reproductive age and their offspring. We determined the cumulative incidence, risk factors and pregnancy outcomes of GDM in Ibadan, Nigeria.

Prospective cohort study.

Ibadan, Southwest Nigeria.

721 pregnant women from the Ibadan Pregnancy Cohort Study participated in the one-step 75 g-oral glucose tolerance test at 24–28 weeks’ gestation.

The primary outcome of the study is the cumulative incidence of GDM. GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups criteria. Secondary outcomes were pregnancy outcomes, which included modes of delivery (CS, spontaneous vaginal delivery), macrosomia (birth weight ≥4.0 kg), gestational age at delivery and birth asphyxia. The risk factors (exposures) examined included sociodemographic, obstetric, clinical, behavioural and lifestyle factors. Bivariate and multivariate Log-binomial regression models were used to identify the independent risk factors of GDM (adjusted for maternal age ≥35 years, income, maternal body mass index, history of pregnancy loss and congenital anomaly) and the associated pregnancy outcomes of GDM (adjusted for maternal age, income and maternal body mass index). Adjusted relative risk (aRR) and 95% CI, used to assess the strength of associations, were reported.

The cumulative incidence of GDM was 20.7%, 95% CI (17.9% to 23.9%). The mean time for the diagnosis of GDM is 25.4±1.42 weeks of gestation. After adjusting for other variables, maternal age ≥35 years: (aRR: 1.48). 95% CI (1.07 to 1.97) p=0.016), maternal obesity (aRR: 1.85, 95% CI (1.26 to 2.30) p=0.002) and a previous history of congenital anomaly (aRR: 2.83, 95% CI (1.97 to 4.07) p

The cumulative incidence of GDM is high among pregnant women in Ibadan. Maternal age ≥35 years, maternal obesity and a history of congenital anomaly were significant independent risk factors for GDM. These factors should be targeted for public health interventions, including lifestyle modification among pregnant women with obesity and early screening and diagnosis of GDM.

Thanks to the introduction of recent national guidelines for treating herpes simplex virus (HSV) encephalitis, health outcomes have improved. This paper evaluates the health system costs and the health-related quality of life implications of these guidelines.

A sub-analysis of data from a prospective, multi-centre, observational cohort ENCEPH-UK study conducted across 29 hospitals in the UK from 2012 to 2015.

Data for patients aged ≥16 years with a confirmed HSV encephalitis diagnosis admitted for treatment with aciclovir were collected at discharge, 3 and 12 months.

Patient health outcomes were measured by the Glasgow outcome score (GOS), modified ranking score (mRS) and the EuroQoL; healthcare costs were estimated per patient at discharge from hospital and at 12 months follow-up. In addition, Quality Adjusted Life Years (QALYs) were calculated from the EQ-5D utility scores. Cost–utility analysis was performed using the NHS and Social Care perspective.

A total of 49 patients were included; 35 were treated within 48 hours, ‘early’ (median (IQR) 8.25 [3.7–20.5]) and 14 were treated after 48 hours ‘delayed’ (median (IQR) 93.9 [66.7–100.1]). At discharge, 30 (86%) in the early treatment group had a good mRS outcome score (0–3) compared with 4 (29%) in the delayed group. According to GOS, 10 (29%) had a good recovery in the early treatment group, but only 1 (7%) in the delayed group. EQ-5D-3L utility value at discharge was significantly higher for early treatment (0.609 vs 0.221, p

This study suggests that early treatment may be associated with better health outcomes and reduced patient healthcare costs, with a potential for savings to the NHS with faster treatment.

The COVID-19 pandemic disrupted maternal healthcare access globally, leading many women to give birth outside of healthcare facilities, often assisted by traditional birth attendants (TBAs). This study explored the experiences of Kenyan women who gave birth outside of healthcare facilities during the COVID-19 pandemic based on the Person-Centered Maternity Care (PCMC) framework.

This study used data from descriptive qualitative indepth interviews with Kenyan women who gave birth outside of healthcare facilities between March and November 2020. Participants lived within the catchment areas of six health facilities in Kiambu and Nairobi counties and were recruited by community leaders and community health workers. Interviews were conducted in 2020 via phone and inductively coded and analysed by a team of researchers.

A total of 28 Kenyan women who gave birth outside of healthcare facilities between March and November 2020 completed indepth interviews.

In this sample, approximately one-third of women were assisted by TBAs, while the majority were supported by friends and family members. Women generally described salient aspects of their care pertaining to the PCMC domain of supportive care. During labour, birth and the immediate postpartum, women received emotional support, basic medical assistance and instrumental support such as preparing food and baths. However, women also described concerns about giving birth outside of healthcare facilities, including poor hygiene and lack of privacy in birthing spaces as well as instances of verbal and physical harassment by TBAs. Overall, women worried about potential complications during birth, and many women delayed seeking postpartum and postnatal care.

Women who were unable to access healthcare facilities during the COVID-19 pandemic relied on TBAs and/or friends and family for support during labour and birth. These women faced gaps in PCMC, specifically related to supportive care. Given that birthing outside of healthcare facilities remains common globally, particularly during emergencies such as pandemics, TBAs should be supported to provide more person-centred care to women giving birth outside of healthcare facilities.

Women with gestational diabetes mellitus (GDM) are at seven-fold to ten-fold increased risk of type 2 diabetes mellitus (T2DM) when compared with those who experience a normoglycaemic pregnancy, and the cumulative incidence increases with the time of follow-up post birth. This protocol outlines the development and validation of a risk prediction model assessing the 5-year and 10-year risk of T2DM in women with a prior GDM diagnosis.

Data from all birth mothers and registered births in Victoria and South Australia, retrospectively linked to national diabetes data and pathology laboratory data from 2008 to 2021, will be used for model development and validation of GDM to T2DM conversion. Candidate predictors will be selected considering existing literature, clinical significance and statistical association, including age, body mass index, parity, ethnicity, history of recurrent GDM, family history of T2DM and antenatal and postnatal glucose levels. Traditional statistical methods and machine learning algorithms will explore the best-performing and easily applicable prediction models. We will consider bootstrapping or K-fold cross-validation for internal model validation. If computationally difficult due to the expected large sample size, we will consider developing the model using 80% of available data and evaluating using a 20% random subset. We will consider external or temporal validation of the prediction model based on the availability of data. The prediction model’s performance will be assessed by using discrimination (area under the receiver operating characteristic curve, calibration (calibration slope, calibration intercept, calibration-in-the-large and observed-to-expected ratio), model overall fit (Brier score and Cox-Snell R2) and net benefit (decision curve analysis). To examine algorithm equity, the model’s predictive performance across ethnic groups and parity will be analysed. Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis-Artificial Intelligence (TRIPOD+AI) statements will be followed.

Ethics approvals have been received from Deakin University Human Research Ethics Committee (2021–179); Monash Health Human Research Ethics Committee (RES-22-0000-048A); the Australian Institute of Health and Welfare (EO2022/5/1369); the Aboriginal Health Research Ethics Committee of South Australia (SA) (04-23-1056); in addition to a Site-Specific Assessment to cover the involvement of the Preventative Health SA (formerly Wellbeing SA) (2023/SSA00065). Project findings will be disseminated in peer-reviewed journals and at scientific conferences and provided to relevant stakeholders to enable the translation of research findings into population health programmes and health policy.

The COVID-19 pandemic has made long-standing nursing workforce challenges apparent on an international scale. Decision-makers must develop multi-pronged approaches to foster the development and maintenance of a strong nursing workforce to support health systems. These approaches require attendance to recruitment and retention initiatives that show promise for stabilising the nursing workforce now and into the future.

Searches were conducted across MEDLINE, Embase, CINAHL and Scopus from January 2014 up to 11 March 2024. This rapid umbrella review protocol is guided by the Joanna Briggs Institute scoping review methodology and adheres to Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. The research question guiding this review is: what structures have healthcare systems put in place to stabilise, support and sustain the nursing workforce? This review will include existing reviews of nursing workforce initiatives with outcomes that impact nursing recruitment and retention. Results will support local health transformation including the development of a jurisdictional nursing workforce stabilisation strategy. Findings from this review will be relevant for the design, refinement and implementation of nursing workforce sustainability strategies in countries around the globe and may apply to strategies for other healthcare workers.

Institutional research ethics board exemption was received. The research team is supported by an advisory group that includes provider and patient partners. The results from this study will inform the Nursing Workforce Strategy for the province of Nova Scotia as part of a larger Canadian Institutes of Health Research-funded project. They will also inform broader planning and strategy in Canada through integration with other evidence-generation activities such as comparative policy analyses and workforce planning exercises. Finally, the results will be published in a peer-reviewed journal.

Registered through Open Science Framework: https://doi.org/10.17605/OSF.IO/CUJYK

Neonatal death and later disability remain common sequelae of hypoxic-ischaemic encephalopathy (HIE) despite the now standard use of therapeutic hypothermia (HT). New therapeutic approaches to brain protection are required. Melatonin is an indolamine hormone with free-radical scavenging, antiapoptotic, anti-inflammatory and gene regulatory neuroprotective properties, which has extensive preclinical evidence of safety and efficacy. Pharmacokinetic (PK) data suggest it is necessary to reach melatonin levels of 15–30 mg/L within 6–8 hours of hypoxia-ischaemia for brain protection. We developed a novel Good Manufacturing Practice (GMP) grade melatonin in ethanol 50 mg/mL solution for intravenous use. In preclinical studies, ethanol is an adjuvant excipient with additional neuroprotective benefit; optimised dosing protocols can achieve therapeutic melatonin levels while limiting blood alcohol concentrations (BACs).

The Acute High Dose Melatonin for Encephalopathy of the Newborn (ACUMEN) Study is a first-in-human, international, multicentre, phase 1 safety study of intravenous melatonin in babies with moderate/severe HIE receiving HT. Sixty babies will be studied over two phases: a dose escalation study including four dose levels to establish the recommended phase 2 dose (RP2D), followed by a 6-month cohort expansion study of RP2D to further characterise PKs and affirm safety. Participants will receive a 2-hour intravenous infusion of melatonin within 6 hours of birth, followed by five maintenance doses every 12 hours to cover the period of HT. Plasma melatonin and BACs will be monitored. The RP2D will be based on the attainment of therapeutic melatonin levels while limiting BACs and the frequency of dose-limiting events (DLEs). A Bayesian Escalation with Overdose Control approach will be used to estimate the risk of DLE per dose level, with a target level of

Approval has been given by the London Central National Health Service Health Research Authority Ethics Committee (25/LO/0170) and UK Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency. Separate approvals have been sought in Ireland and Australia. Dissemination will be via peer-reviewed journals, conference presentations, public registries and plain language summaries for parent/legal guardian(s), in accordance with national requirements.

ISRCTN61218504. EU CT: 2025-520538-49-00.

Publication based on the UK protocol V.3.0, 08 May 2025

Endovascular aortic aneurysm repair (EVAR) requires long-term surveillance to detect and treat postoperative complications. However, prediction models to optimise follow-up strategies are still lacking. The primary objective of this study is to develop predictive models of post-operative outcomes following elective EVAR using Artificial Intelligence (AI)-driven analysis. The secondary objective is to investigate morphological aortic changes following EVAR.

This international, multicentre, observational study will retrospectively include 500 patients who underwent elective EVAR. Primary outcomes are EVAR postoperative complications including deaths, re-interventions, endoleaks, limb occlusion and stent-graft migration occurring within 1 year and at mid-term follow-up (1 to 3 years). Secondary outcomes are aortic anatomical changes. Morphological changes following EVAR will be analysed and compared based on preoperative and postoperative CT angiography (CTA) images (within 1 to 12 months, and at the last follow-up) using the AI-based software PRAEVAorta 2 (Nurea). Deep learning algorithms will be applied to stratify the risk of postoperative outcomes into low or high-risk categories. The training and testing dataset will be respectively composed of 70% and 30% of the cohort.

The study protocol is designed to ensure that the sponsor and the investigators comply with the principles of the Declaration of Helsinki and the ICH E6 good clinical practice guideline. The study has been approved by the ethics committee of the University Hospital of Patras (Patras, Greece) under the number 492/05.12.2024. The results of the study will be presented at relevant national and international conferences and submitted for publication to peer-review journals.

Despite extensive efforts in HIV prevention, significant barriers to accessing interventions such as HIV pre-exposure prophylaxis (PrEP) persist in Canada. Although PrEP has demonstrated efficacy in preventing HIV transmission, various structural, social and systemic factors continue to impede its widespread adoption and use. These factors influence the uptake (acceptance and access) and use (adherence and retention) of PrEP. The purpose of this scoping review is to examine the existing body of evidence regarding the barriers and facilitators to uptake and use of PrEP in Canada. By identifying these factors, the review aims to inform future research, policy development and interventions to improve PrEP access and its integration into HIV prevention strategies in Canada.

This scoping review will focus on studies involving HIV-seronegative individuals in Canada who are either eligible for or currently using PrEP as an HIV prevention option. The review will consider barriers and facilitators within services, programmes, policies or practices related to HIV prevention in Canada. Eligible studies will include experimental, quasi-experimental, observational or qualitative designs. Studies that do not address PrEP or HIV prevention, or that involve populations not aligned with the inclusion criteria, will be excluded. The review will involve searching a range of key databases, including MEDLINE, Embase, PsycINFO, Cochrane Library, CINAHL, Scopus, Web of Science and TRIP, with no language restrictions, and focusing on publications from 2016 onward. Two independent reviewers will screen titles and abstracts, followed by full-text assessment and data extraction, using Covidence. Data will be analysed narratively, with a specific focus on subgroup analyses of key populations. The findings will be synthesised to provide an overview of the key themes, trends, and evidence gaps identified within the existing literature.

This piece of research will not involve human participants and will solely use already published data. Consequently, ethics approval is not necessary. The findings will be disseminated through peer-reviewed journal articles and conference presentations and may be of relevance to governmental health agencies and local HIV/AIDS service organisations.

The protocol has been registered on Open Science Framework registries at https://doi.org/10.17605/OSF.IO/69WJA.

Elevated left ventricular end-diastolic pressure (LVEDP) in ST-segment elevation myocardial infarction (STEMI) has been studied in patients who received thrombolysis or who were treated early in the primary percutaneous coronary intervention (PCI) era; LVEDP was found to be a predictor of adverse outcomes in these retrospective post hoc analyses. The aim of the current analysis is to assess the prognostic value of the elevated LVEDP in STEMI patients undergoing primary PCI in current contemporary practice.

Prospective, single-centre study.

Our study enrolled STEMI patients with elevated LVEDP undergoing primary PCI at John Hunter Hospital, Newcastle, Australia.

The primary endpoint was the combination of 12-month all-cause mortality and heart failure admissions, comparing different quartiles of LVEDP.

A total of 997 patients underwent primary PCI at our hospital during the 5-year study period (age: 64±13 years, males: 73%; n=728) from 1 January 2015 to 31 December 2019. The median LVEDP for the whole cohort was 27 mm Hg (IQR: 22–31 mm Hg). The median LVEDP was 17 mm Hg (IQR: 13–18 mm Hg) and 33 mm Hg (IQR: 30–36 mm Hg) for 1st and 4th quartiles respectively (p

LVEDP is an independent predictor of adverse outcomes in STEMI patients, despite a relatively normal LVEF. Further prospective studies are needed to assess the effects of early reduction in LVEDP on the prognosis.

Approximately 1 in 13 Australian children have a neurodevelopmental disability. This project aims to assess the effectiveness and implementation of an online parenting support programme, Parenting Acceptance and Commitment Therapy (PACT) Online, for parents of children with neurodevelopmental disabilities for improving the parent–child relationship and parent and child outcomes.

This hybrid type 1 randomised controlled trial will focus on evaluating intervention effectiveness and understanding the context for implementation. The primary outcome is observed emotional availability within parent–child interactions assessed at postintervention (12 weeks postbaseline) with additional measurement at follow-up (6 months postbaseline). Secondary outcomes include (1) parent-reported emotional availability, (2) parental mindfulness, (3) parent mental health, (4) psychological flexibility, (5) adjustment to child’s disability, (6) health behaviour and (7) regulatory abilities as well as child outcomes of (1) mental health, (2) adaptive behaviour and (3) regulatory abilities. Evaluation of implementation will include an economic evaluation of costs and consequences, and an implementation analysis grounded in the consolidated framework for implementation research with a focus on contextual factors influencing implementation.

Ethical approval has been obtained from the University of Queensland Human Research Ethics Committee (023/HE000040). Dissemination of study outcomes will occur through the appropriate scientific channels. Long-term implementation will be grounded within the implementation analysis and occur in partnership with the partner organisations and consumer engagement panel. This will include releasing the PACT Online intervention as a massive open online course on the edX platform if support for intervention effectiveness and implementation is found.

ACTRN12623000612617; this trial has been registered with the Australian New Zealand Clinical Trials Registry.

To determine associations between arm and ankle systolic blood pressures (SBPs), develop and validate a multivariable model predicting arm SBP from ankle SBP, and investigate associations between ankle SBP, cardiovascular disease and mortality.

Ankle-arm SBP differences were examined in two-stage individual participant data (IPD) meta-analyses using multivariable hierarchical linear regression models. Models were used to derive and validate a prediction model for arm SBP based on ankle SBP. Model performance was assessed using area under the receiver operating characteristic (AUROC) curve analyses. Prognostic associations of ankle SBP with outcomes were examined using Cox proportional hazards models.

Searches identified cohorts for the Inter-arm Blood Pressure Difference IPD (INTERPRESS-IPD) Collaboration from Medline, Old Medline, Medline in process, Embase and CINAHL databases from inception until January 2017; unpublished data were also sought. Required primary outcomes were all-cause mortality, cardiovascular mortality, and/or fatal and non-fatal cardiovascular events.

Prospective studies from community, primary care or general clinic settings, without language restriction, that recorded SBP in both arms were eligible. Adults aged ≥18 years with SBP measured in all four limbs, in a supine position, were included in the current analyses. People with peripheral artery disease were excluded.

Anonymised datasets were individually cleaned and then combined into a single dataset for the INTERPRESS-IPD Collaboration.

The current dataset included 33 710 participants from 14 studies; mean age 58 years, 45% female, mean baseline arm blood pressure 138/80 (SD: 20/12) mm Hg. Mean ankle SBP was 12.0 mm Hg (95% CI 8.8 to 15.2) higher than arm SBP. The multivariable model predicting arm SBP from ankle SBP demonstrated excellent performance (AUROC curves, sensitivities and specificities were >0.82, 0.80 and 0.82, respectively, at all BP thresholds from 130 to 160 mm Hg). Model performance was superior to existing arithmetic formulae.

Ankle SBP was neither associated with all-cause nor cardiovascular mortality (HR 1.000 (0.997 to 1.002; p=0.682) and 1.001 (0.996 to 1.005; p=0.840), respectively). However, lower-reading ankle SBP was associated with fatal or non-fatal cardiovascular events (HR 1.005 (1.002 to 1.007; p

On average, ankle SBP is 12 mm Hg higher than arm SBP. Estimating individual arm SBP from ankle SBP measurements with a multivariable model is more accurate than existing fixed arithmetic formulae. This model, operationalised in an online calculator (https://ablebp.research.exeter.ac.uk/), could facilitate hypertension management and cardiovascular care for people unable to have arm SBP measured.

CRD42015031227.

Intensive care units (ICUs) manage patients with or likely to have one or more life-threatening acute organ failures that might require the use of invasive supportive therapies. The use of physical restraint is frequent, with rates up to 50%, and usually initiated to maintain patient safety especially if the patient is agitated. Physical restraints have been associated with delirium, post-traumatic stress disorder and physical injuries while restricting patients’ individual freedom. Moreover, the incidence of invasive therapeutic devices’ self-removal by patients might not be decreased by physical restraint use. No recommendation is available concerning ICU patients and physical restraint management, despite being a daily practice. The main objective is to evaluate whether a strategy aimed at decreasing physical restraint use in ICU patients with that of a strategy based on routine and subjective caregivers’ decision is safe and efficient.

ARBORea is a multicentre randomised, stepped-wedge trial testing an innovative, dedicated web-based, multiprofessionally developed, experts validated, nursing management strategy in comparison with standard care. The primary outcome is physical restraint use rate (effectiveness) measured at least every 8 hours and incidents’ rate (tolerance) defined as the rate of incidents attributable to non-compliance, corresponding to the deterioration or self-removal of critical devices, a fall or self-aggressive or heteroaggressive behaviours. Planned enrolment is 4000 ICU adult participants at 20 French academic and non-academic centres. Safety and long-term outcomes will be evaluated.

Trial results will be reported according to the Consolidated Standards of Reporting Trials 2010 guidelines. Findings will be published in peer-reviewed journals and presented at local, national and international meetings and conferences to publicise and explain the research to clinicians, commissioners and service users. The trial is funded by the French Ministry of Health and has been approved by the French local ethics committee (Comité de Protection des Personnes Sud-Ouest et Outre-Mer 2, Toulouse, France with registration number: 2020-A02904-35).

(ClinicalTrials.gov) NCT04957238 on 12 July 2021 before first inclusion in study.