Parental psychological challenges and poor well-being are key factors in shaping both the quality of parent-child interactions and child development. Specifically, maternal psychological distress is a central determinant of child development. Elevated levels of distress in mothers are associated with poorer child cognitive, behavioural and social-emotional outcomes, with effects persisting into adolescence and adulthood. While this highlights the critical importance of early prevention and intervention efforts to support parents, postpartum mental healthcare remains limited, despite ongoing and evident needs.

This protocol outlines a 2-year longitudinal follow-up study investigating the impact of a secondary perinatal programme (ie, Toi, Moi, Bébé), completed by mothers during pregnancy, and its impact on children’s cognitive and social-emotional functioning at 24 and 48 months. Further, the study aims to explore whether maternal self-efficacy and emotion regulation may serve as potential mediators or moderators of the relationship between programme participation and child development outcomes. The research aims to leverage the Toi, Moi, Bébé programme, by recruiting mother-child dyads (n=250) in which the mothers participated in the programme during pregnancy. Mothers were randomly assigned to complete the parenting well-being intervention either independently or with added telephone support. Participants who consent will be invited to take part in a two-wave follow-up at 24 months (T1) and 48 months postpartum (T2). At both time points, mothers will complete demographic questionnaires and standardised measures assessing maternal well-being (Generalised Anxiety Disorder-7, Edinburgh Postnatal Depression Scale and Perceived Stress Scale), child cognitive functioning (Ages and Stages Questionnaire-3 and MacArthur-Bates Communicative Development Inventory), child social-emotional functioning (Ages and Stages Questionnaire, Social Emotional—second Edition-2 and Child Behaviour Checklist for Ages 1.5–5), maternal emotion regulation (Cognitive Emotion Regulation Questionnaire) and maternal self-efficacy (Parental Cognitions and Conduct Towards the Infant Scale & Me as a Parent Scale). Parents’ perceptions of their parenting experience will be measured using the Parental Reflective Functioning Questionnaire. Mother-child interaction, parenting quality and cognitive stimulation in the home environment will be measured using a brief virtual interview (StimQ₂-Toddler) and a naturalistic observation assessment (Parenting Interactions with Children: Checklist of Observations Linked to Outcomes). Using RStudio, linear mixed models will be used to assess the impact of the intervention (online intervention only vs only with telephone support) on child cognitive and social-emotional development at T1 and T2. In parallel, separate models will be conducted to examine associations between maternal emotion regulation and self-efficacy on the child development outcomes at the same timepoints. Exploratory analyses will be conducted to examine potential moderating effects of child sex and group assignment on the associations between maternal emotion regulation and self-efficacy and child developmental (cognitive and socioemotional) outcomes, using causal inference models.

The current study has been registered, reviewed and approved (MP-37-2025-10894) by the Research Institute of the McGill University Health Centre Research Ethics Board. Findings from this research will be disseminated through peer-reviewed open access publications, and presentations at national and international conferences.

NCT05110456.

To determine the prevalence and factors associated with pain-related disabilities among First Nations people living off-reserve in Canada in 2017.

Secondary analysis of the 2017 Aboriginal Peoples Survey, a cross-sectional survey of individuals living in private dwellings throughout Canada.

First Nations people living off-reserve aged 15 years and older (n=9115; weighted n=482 066).

Pain-related disabilities, defined as pain-related activity limitations lasting ≥6 months.

Overall, 22.1% (95% CI 20.9% to 23.4%) of First Nations people living off-reserve reported pain-related disabilities. Prevalence was higher among females (26.1%; 95% CI (24.3% to 28.0%)), increased with age (34.3%; 95% CI (30.3% to 38.5%) among those 45 to 54 years) and was similar across geographic areas (ranging from 21.0%; 95% CI (18.3% to 23.9%) to 22.5%; 95% CI (20.8% to 24.2%)). Pain-related disabilities increased with the number of coexisting disabilities (96.2%; 95% CI (94.3% to 97.5%) among those with >3 disabilities) and was highest among those reporting physical disabilities (ranging from 88.2%; 95% CI (85.6% to 90.4%) for those with mobility disabilities to 91.0%; 95% CI (88.6% to 92.9%) for those with disability related to flexibility). Regression models suggested that individuals with unmet basic needs, housing dissatisfaction, unmet healthcare needs, a history of mental health consultations, part-time or no employment, chronic conditions, residential school attendance or a low sense of belonging were more likely to report pain-related disabilities.

Pain-related disabilities are common among First Nations people living off-reserve, and their aetiology may be multifactorial. Continued collaboration with Indigenous partners is required to contextualise findings and to inform culturally responsive clinical and rehabilitation strategies.

Healthcare logistics involves the coordination of resources, services and infrastructure to ensure timely and efficient care delivery. Process mining offers data-driven insights into logistical workflows such as patient transport, inventory management and scheduling. This systematic review aims to synthesise evidence on the application of process mining in healthcare logistics, focusing on its impact on operational efficiency, resource utilisation and service delivery.

A systematic search will be conducted in MEDLINE, Embase, Google Scholar, Web of Science and ABI/Inform for studies published from 1999 onward. Eligible studies will include observational studies, case reports, conference papers and meta-analyses focusing on process mining applications to logistical processes in healthcare settings. Studies screening, data extraction and methodological quality assessment will be conducted using the Mixed Methods Appraisal Tool. Data will be extracted on key dimensions and performance indicators and will be presented in a structured format. A narrative synthesis will be conducted, and findings will be categorised and thematically analysed where appropriate. Primary outcomes include improvements in logistical efficiency, traceability, resource utilisation and sustainability. Secondary outcomes include implementation challenges, data integration issues and limitations in applying process mining techniques to logistical workflows.

The results of the systematic review will be disseminated via publication in a peer-reviewed journal and presented at a relevant conference. The data we will use do not include individual patient data, so ethical approval is not required.

CRD420251164812.

Effect size and event rate estimation is necessary for sample size calculation in randomised clinical trials. Overestimation of the effect size and event rate can lead to inadequately powered studies and increased probability of false negative results. This is common in trials involving critically ill patients. However, such overestimation has not been systematically evaluated in trials involving neurocritical care. We aimed to conduct a systematic review of published randomised clinical trials involving critically ill neurological patients, to determine the accuracy of effect size and event rate estimation.

We will review randomised clinical trials involving adult critically ill neurological patients that were published from 2015 onwards in selected clinically useful and high-impact journals. We will include randomised clinical trials reporting a binary or time to event outcome, using two study groups, and a superiority design testing the efficacy of diagnostic, monitoring, therapeutic or process interventions. All eligible studies must report an estimated event rate in the control group and estimated effect size. All relevant studies will be identified through database searches. All study selection and data extraction will be conducted by two independent reviewers. We will use a random-effects model for pooling data. This review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines. Accuracy of effect size and event rate estimation will be evaluated by comparing the estimated and observed values. The association between the accuracy of the individual randomised clinical trial effect size and event rate estimation and rejection of the null hypothesis will be evaluated using logistic regression analysis. Multivariable linear regression analysis will be used to explore the factors associated with accuracy of effect size and event rate estimation. In addition, we will perform subgroup analysis by impact factor of the published journals, sample size of the studies and risk of bias.

As this systematic review will use data from previously published studies, it does not require ethics approval. Findings of this systematic review will be published in a peer-reviewed journal and will be presented at specialty-based conferences. The study will be included in the higher degree research thesis of the primary author.

CRD420251106394.

To evaluate the available virtual reality (VR) applications for treating perinatal mental health disorders, focusing on their effectiveness in reducing symptoms such as anxiety and depression, which are common during the perinatal period.

Rapid scoping review adhering to the Joanna Briggs Institute guidelines and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review (PRISMA-ScR), with adjustments based on the Cochrane Rapid Reviews guidelines.

Medline, PsychInfo, Embase, Evidence-Based Medicine (EBM) Reviews using Ovid and Web of Science were searched through 20 February 2024.

Studies were included if they were written in English or French, provided details on the VR technology, described the assessment of perinatal mood disorders and specified the outcomes measured and the methodological approach used. Review and editorial articles were excluded as well as abstracts and posters.

One reviewer extracted study characteristics (eg, design, participants, VR components, outcomes) and a second reviewer verified accuracy; study quality was assessed using the National Institute of Health (NIH) Quality Assessment of Controlled Intervention Studies tool, and findings were synthesised narratively and in tabular form.

A total of 425 records were identified. After removing duplicates, 308 records were screened by title and abstract. Of these, 74 full texts were assessed for eligibility, resulting in 10 studies being included for data extraction. These final studies were primarily conducted in high-income countries from 2019 to 2024. 8 of 10 (80%) were randomised controlled trials, employing VR through head-mounted displays. Studies predominantly targeted non-severe cases of anxiety and depression, with VR environments ranging from nature scenes to therapeutic content. Results suggest a positive impact of VR interventions on reducing anxiety and depression levels among participants.

Studying VR appears to be a promising avenue for developing options to manage perinatal mental health. The immersive nature of VR may provide opportunities for emotional relief and support during this critical period through engaging experiences which can reduce symptoms of anxiety and depression. However, the body of research remains limited, indicating a need for further studies to explore the long-term benefits and potential integration of VR into perinatal healthcare practices. The promising results from initial studies encourage continued exploration and development within this innovative therapeutic field.

https://doi.org/10.17605/OSF.IO/VFZC7.

The management of severe traumatic brain injury (sTBI) in the intensive care unit (ICU) is focused on preventing secondary brain insults, by ensuring adequate cerebral perfusion, oxygenation and substrate delivery. Despite optimisation of intracranial pressure (ICP) and cerebral perfusion pressure (CPP) using evidence-based guidelines, brain tissue hypoxia can still occur and is strongly associated with adverse functional outcomes post sTBI.

The Brain Oxygen Neuromonitoring in Australia and New Zealand Assessment – Global Trial (BONANZA-GT) is an international, two-arm, open-label, parallel group, randomised controlled trial comparing sTBI management incorporating early brain tissue oxygen (PbtO₂) monitoring and optimisation, with ICP/CPP-based management alone. A total of 860 adults admitted to participating institutions with non-penetrating sTBI and requiring insertion of an ICP monitor (as determined by the treating neurosurgeon) will be enrolled. The primary outcome is the proportion of patients with favourable neurological outcomes, as defined by a Glasgow Outcome Score-Extended (GOS-E) >4, at 6 months following injury. Key secondary outcomes include all-cause mortality at ICU discharge, hospital discharge, adverse events, as well as hospital and ICU length of stay and GOS-E at 12 months. The BONANZA-GT will determine whether a protocolised therapeutic strategy guided by continuous PbtO₂ monitoring in addition to ICP/CPP targets results in improved neurological outcomes when compared with standard care using ICP/CPP-guided management alone.

Approval has been obtained from relevant ethics boards in every jurisdiction that is participating in the trial. Inclusion of adults who lack capacity for informed consent will be governed in accordance with the legal requirements of each participating site. Study findings will be presented at scientific meetings and disseminated via peer-review publications.

Australian and New Zealand Clinical Trials Registry (ACTRN 12619001328167).

Persistent pain after finishing breast cancer treatment is a common and disabling problem. The current state-of-the-art pain management advocates, in addition to biomedical (non-)pharmacological approaches, a biopsychosocial rehabilitation approach to address persistent pain, combining pain science education with promoting an active lifestyle through self-regulation techniques. We propose testing an innovative eHealth self-management support programme for this purpose in the breast cancer population with persistent pain after finishing cancer treatment. This delivery mode is believed to reduce barriers to pain self-management by providing timely, safe and cost-effective assistance addressing the biopsychosocial needs of patients. Utilising a chatbot format, the eHealth programme delivers pain science education and promotes physical activity (PA), personalised through decision-tree-based algorithms to support pain self-management. The programme aims to empower patients with understanding, coping skills and self-management techniques to reduce pain-related disability and enhance participation in daily life. The primary objective is to determine programme effectiveness compared with (1) usual care (superiority) and (2) a similar face-to-face pain self-management support programme (non-inferiority).

A pragmatic, three-arm randomised controlled trial was started in April 2024 at the University Hospitals of Antwerp and Leuven and primary care settings in Belgium. Participants are breast cancer survivors with persistent pain after finishing cancer treatment. Two hundred seventy participants will be randomised to one of three trial arms: (1) eHealth self-management support programme, (2) usual care or (3) a face-to-face self-management support programme. The ‘eHealth self-management support programme’ begins with a pain science education (PSE) module to initially convey key pain-related concepts and provide personalised pain management tips. Then, the programme progresses to daily activity planning to promote an active lifestyle. Guided by the Health Action Process Approach (HAPA) model, participants set and review daily activity goals and track progress. The eHealth self-management programme uses a chatbot and is accessible on any digital device. The ‘usual care programme’ involves sending the participants a study-specific brochure by postal mail and does not include any formal PSE and/or PA programmes. They may pursue or continue self-initiated care. In Belgium, usual care primarily involves pharmacological treatment, general advice on PA and the provision of informational brochures. The ‘face-to-face self-management support programme’ mirrors the eHealth intervention, combining PSE with PA coaching. It starts with three individual sessions with a trained physical therapist for biopsychosocial assessment and PSE, followed by six sessions on goal setting and active lifestyle coaching. The educational content is delivered both verbally and in written form. The primary outcome will be pain-related disability 6 months after baseline assessment. As a key secondary outcome, the effect on pain beliefs and attitudes will be investigated after the educational part of the eHealth and face-to-face programme (ie, at 6 weeks after baseline). Other secondary outcomes related to other dimensions of pain and physical-, psychosocial- and health-economic outcomes will be assessed at 12 weeks and 6 and 12 months after baseline as well.

The study will be conducted in accordance with the Declaration of Helsinki (2024). The protocol has been approved by the ethical committee of the University Hospitals of Leuven and Antwerp. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses. Ethical Committee of the University Hospitals Leuven and Antwerp: BUN B3002023000132.

ClinicalTrials.gov Identifier: NCT06308029.

Acute abdominal pain is a chief complaint in emergency departments and represents 7%–10% of emergency room (ER) visits. Acute appendicitis represents 15% of the causes of abdominal pain and 62% of the causes that require surgical treatment. Opioid analgesia has been evaluated in clinical trials, and they have determined it does not impact diagnostic accuracy. Despite evidence, withholding analgesia is still a common practice. Pain severely impacts quality of life and analgesia has become essential in humanised medicine. We aim to determine the safety and effectiveness of different opioid regimens for adult patients that present to the ER with acute suspected appendicitis.

We will search MEDLINE and Embase via Ovid, and the Cochrane Central Register of Controlled Trials without restrictions on the study publication date. Screening, extraction and risk of bias assessment will be performed in duplicate. We will use the Cochrane Risk of Bias Assessment Tool. We will perform both pairwise meta-analysis and network meta-analysis (NMA) if transitivity and coherence principles are met. Heterogeneity will be evaluated using the I² and ² and using the thresholds recommended by Cochrane. We will perform sensitivity analysis based on the pre-established potential effect modifiers, risk of bias and data that required transformation or imputation. Publication bias will be addressed by using funnel plots on a pairwise level. We will assess the strength of the body of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE) per outcome, and evidence from the NMA will be assessed using the GRADE approach for NMA.

Approval by an ethics committee is not required for this study since no personal information will be handled. Information will be disseminated by publication on a peer-reviewed journal.

CRD42024583804.