Processed electroencephalography (pEEG) monitoring is commonly employed to assess the level of hypnosis under anaesthesia, although it is susceptible to various non-brain-related artefacts. Several sources of artefacts have been published, but how these sources affect the pEEG and their related hypnotic indices have not been summarised before. This scoping review will summarise the published literature on how non-pharmacological artefacts affect pEEG monitoring during anaesthesia andintensive care, including their influence on the hypnotic index and the underlying mechanisms of interference.

Non-pharmacological, non-brain-related sources of artefacts affecting human patients under anaesthesia or intensive care will be included. The covered concepts include the sources of interference affecting pEEG in which the artefact causes the hypnotic index to no longer be reflective of the depth of hypnosis, how they affect the hypnotic index, and the suspected mechanism by which they affect the pEEG monitor. Databases to be searched will include PubMed, Ovid MEDLINE, Embase, Cochrane Library, CINAHL and the Web of Science. Grey literature will include sources from Google Scholar, the Web of Science, preprint repositories and reference lists of included studies and review papers. The search will be conducted on 19 June 2025, followed by a later repeat search for new articles once the data from the initial search have been extracted. The search will be limited to English articles. Search results will be imported into Covidence for screening. Data extraction will be conducted by two extractors independently, and the data will be summarised in tables.

There are no ethical or safety concerns associated with this study. Ethics approval was not obtained as this scoping review will summarise data from previously published sources, and the findings will be published in a peer-reviewed journal.

Patient-reported experience measures (PREMs) are measures of patients’ perceptions of care they receive. PREMs are critical in developing and evaluating programmes that aim to improve patient healthcare experiences and quality of care (QoC) according to patient-defined needs. This review aims to map key domains of PREMs across distinct healthcare technical areas and life stages from globally available literature.

A scoping review adapting Arksey and O’Malley’s framework and Joanna Briggs Institute’s guidelines for the conduct of scoping reviews.

Google Scholar, PubMed, WHO, US Academy of Medicine and USAID Momentum.

PREMs literature from electronic repositories of grey and peer-reviewed publications, published in English historically up to September 2023.

Two lead reviewers with support from the technical working group co-created a review framework of healthcare technical areas, life stages and PREMs domains. We screened eligible articles, prioritising reviews except for technical areas with no reviews, where we then selected individual studies. We charted, analysed and synthesised data from 52 eligible articles.

PREMs literature has recently increased, especially in low-income and middle-income countries (LMICs), although studies in high-income countries (HICs) dominate in proportion (n=38; 73.1%). Out of 52 eligible articles, technical areas with most publications were sexual and reproductive health (n=21; 40.4%) and general outpatient care (n=11; 21.2%). Studies in adulthood (n=24; 46.2%) and from pregnancy and birth to postnatal (n=16; 30.8%) were most represented. PREMs studies reported mostly on communication and rapport (n=33; 63.5%) and respect and dignity (n=42; 80.8%) domains. Nearly a quarter (n=12; 23.1%) of the articles included only validated tools; the rest included a combination of validated and unvalidated measures. Of the tools relating to life stages of babies, younger children and older adults, the majority (n=17; 94.4%) included patient proxies.

PREMs, as an important component of QoC measurement, are increasing across several healthcare technical areas and life stages with commonalities and notable distinctions in measurement domains and tools. Evidence on PREMs largely comes from HICs. Evidence on critical, yet sometimes overlooked domains, highlights key QoC implementation gaps. The adaptation and utilisation of PREMs in programmes, especially in LMICs and under-represented technical areas, present opportunities to close the QoC disparities in those settings. Strategic, concerted efforts towards the harmonisation of PREMs tools across multiple life course stages and technical areas are critically needed in high-level quality improvement efforts.

Persons with serious mental illness (SMI) often have coexisting medical conditions and experience a significantly reduced life expectancy compared with the general population. Peer support is considered an effective care approach for this population, and with rapid technological advancements, digital peer support, such as the DigiPer mobile application, can be a feasible self-management tool for persons with SMI. The study aims to assess the feasibility of DigiPer for persons with SMI in the Norwegian community mental health service settings.

This feasibility study will incorporate both qualitative and quantitative methods. The study consists of three phases: (1) simulation-based training among peer support workers using qualitative individual interviews; (2) pre–post study of DigiPer among peer support workers and service users using quantitative questionnaires and (3) process evaluation for peer support workers and service users using qualitative individual interviews. Peer support workers (n=5) and service users with SMI (n=15) will be recruited to evaluate the feasibility of DigiPer.

Ethics approval was granted from the Regional Committee for Medical Research Ethics (reference no. 853041), along with an assessment of processing of personal data by the Norwegian Agency for Shared Services in Education and Research (reference no. 810990). Findings will be disseminated through peer-reviewed publications and presentations at relevant national and international scientific conferences.

Gestational weight gain (GWG) is an important indicator of maternal nutrition to be monitored during pregnancy. However, there is no evidence-based tool that can be used to monitor it across all geographic locations and pre-pregnancy body mass index (BMI) categories. The WHO is undertaking a project to develop GWG charts by pre-pregnancy BMI category, and to identify GWG ranges associated with the lowest risks of adverse maternal and infant outcomes. This protocol describes all the steps that will be used to accomplish the development of these GWG charts.

This project will involve the analysis of individual participant data (researcher-collected or administrative). To identify eligible datasets with GWG data, a literature review will be conducted and a global call for data will be launched by the WHO. Eligible individual datasets obtained from multiple sources will be harmonised into a pooled database. The database will undergo steps of cleaning, data quality assessment and application of individual-level inclusion criteria. Heterogeneity of maternal weight and GWG will be assessed to verify the possibility of combining datasets from multiple sources and regions into a single database. Generalized Additive Models for Location, Scale and Shape will be applied for the construction of the centile curves. Diagnostic measures, internal and external validation procedures will also be performed.

This project will include an analysis of existing study de-identified data. To be included in the pooled database, each included study should have received ethics approvals from relevant committees. Manuscripts will be submitted to open-access journals and a WHO document will be published, including the GWG charts and cut-offs for application in antenatal care.

Streptococcus pneumoniae serotype 3 (SPN3) remains a significant contributor to invasive pneumococcal disease globally, despite its inclusion in widely administered vaccines. The next generation of pneumococcal vaccines may confer better protection against this serotype, reducing disease burden. We describe an ethically approved protocol for a double-blind randomised controlled trial assessing the impact of VAXNEUVANCE (15-valent pneumococcal conjugated vaccine (PCV15)) and 0.9% saline (placebo) on the acquisition, density and duration of SPN3 carriage using a controlled human infection model.

Healthy adults aged 18–50 years will be randomised 1:1 to receive PCV15 or placebo. Participants will be considered enrolled on the trial at vaccination. One month following vaccination, all participants will be intranasally inoculated with SPN3. Following inoculation, participants will be followed up on days 2, 7, 14 and 28 to monitor safety, SPN3 colonisation status, density and duration, as well as immune responses. The primary endpoint of the study is to assess the rate of SPN3 acquisition between vaccinated and unvaccinated participants defined by classical microbiological methods. Secondary endpoints will determine the density and duration of SPN3 colonisation and compare the immune responses between study groups. An exploratory cohort of 5 participants will be asked to consent to a nasal biopsy procedure during a screening visit and a second nasal biopsy 28 days after PCV15 vaccination. This cohort will only receive PCV15 and will not be challenged. Through this exploratory cohort, we will explore gene expression changes induced by PCV15 vaccination and their visualisation (spatial location) within the nasal tissue.

This protocol has been reviewed by the sponsor, funder and external peer reviewers. The study is approved by the NHS Research and Ethics Committee (Reference: 24/SC/0388) and by the Medicines and Healthcare Products Regulatory Agency (Reference: CTA 21584/0485/001-0001).

NCT06731374 – ISRCTN91656864.

Depressed mood is a psychological state characterised by sadness or loss of interest in activities, is a common symptom that accompanies most major mental disorders. It is therefore reasonable to consider it as a transdiagnostic target, which when addressed, may improve the functioning and quality of life of persons with lived experience of mental disorders. However, there is limited understanding of the depressed mood as a transdiagnostic target across major mental disorders. Therefore, this scoping review aims to synthesise knowledge on depressed mood, its measurement and interventions among persons with anxiety and/or psychosis.

This scoping review followed Arksey and O'Malley’s framework. Peer-reviewed articles and grey literature published from January 1988 to April 2024 were searched in the following databases: Medline/PubMed, Scopus, Web of Science, Africa-Wide Information, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, SocINDEX, Humanities International Complete, Sabinet, Open Grey and Google Scholar. Articles were screened at title, abstract and full article levels. Data extracted were analysed using thematic analysis and reported following Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines. We also consulted stakeholders such as lived experience experts, clinicians and researchers to contextualise our findings.

We screened 245 full articles out of the 4039 hits and included 28 articles in this review. Although depressed mood is conceptually different from clinical depression, the terms are used interchangeably in the literature. The prevalence of depressed mood in psychosis was 7.3–33.3%, with no prevalence studies specific to anxiety disorders. Commonly used outcome measures included Beck’s Depression Inventory (n=6) and Patient Health Questionnaire-9 (n=5). Psychosocial conservative interventions such as cognitive–behavioural therapy were the most common interventions. Other interventions, including yoga, pharmacotherapy and Ecology Momentary Interventions, were also reported. All interventions were reported to improve depressed mood, and most were implemented in high-income settings. Stakeholders, including lived experience experts, concurred on the importance of using depressed mood as a transdiagnostic target, viewing it as a ‘window’ for early identification and management of many common mental disorders.

There is a need to clarify the definition and diagnostic cut-off points on common outcome measures of depressed mood. There is also a need for increased research on depressed mood as a viable transdiagnostic target in anxiety and/or psychosis with a special focus on low-to-middle income countries.

Depressed mood is an important and prevalent transdiagnostic target with great promise for early management in anxiety and/or psychosis. Valid diagnostic and measurement tools are developing, and so are the targeted interventions in the context of anxiety and/or psychosis.

Mistreatment and obstetric violence constitute significant human rights violations with profound implications for maternal mental health. These detrimental practices persist globally, particularly in contexts where underfunded health systems, workforce shortages and entrenched gender inequalities intersect, depriving women of adequate psychosocial support and culturally sensitive mental healthcare. Although awareness of the immediate harms of mistreatment is increasing, its cumulative effects throughout the maternal care continuum remain insufficiently understood. This review will synthesise evidence on the impact of mistreatment on perinatal mental health, identify critical gaps and advocate for systemic change.

This systematic review and meta-analysis protocol complies with the guidelines set forth by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols. A thorough literature search will be executed across multiple electronic databases, including CINAHL—Cumulative Index to Nursing and Allied Health Literature, Embase via Ovid, MEDLINE, PsycInfo, PubMed, Scopus, as well as other significant or specialised databases and grey literature. The review will incorporate only non-randomised study types and observational studies (cohort, cross-sectional, case-control), along with mixed-method and qualitative studies. Abstract and full-text screening will be performed by two reviewers using Covidence. The methodological quality of the included studies will be assessed using the Newcastle-Ottawa Scale for observational studies, the Risk of Bias in Non-Randomised Studies of Interventions, the Critical Appraisal Skills Programme and the Mixed Methods Appraisal Tool. Statistical heterogeneity will be evaluated using the Higgins test. Meta-analysis will be conducted using R statistical software V.4.4.4, employing random effects models to determine the weights. The study results will be reported sequentially, beginning with primary outcomes, followed by secondary outcomes and significant subgroup outcome analyses.

Ethical approval is not required as no original data will be collected. The findings of this review will be disseminated through publication and conference presentations.

CRD420251044379.

Cluster randomised trials (CRTs) can be at risk of bias driven by differential identification and recruitment of participants across treatments, posing a threat to the validity of findings. We explored the awareness and importance, among CRT researchers, of the recommended bias mitigation measures.

Qualitative interview study using semistructured interviews.

Participants were researchers involved in conducting CRTs, including investigators, statisticians and trial coordinators. 24 participants, including statisticians (n=13, 54.2%), clinical investigators (n=9, 37.5%) and trial coordinators (n=2, 8.3%), were interviewed; with representation from the UK (n=10, 41.7%), Australia (n=5, 20.8%) and the USA (n=4, 16.7%).

Participants exhibited differing levels of knowledge related to biases. Some participants demonstrated high levels of knowledge, but we also identified prevalent misconceptions, with some evidence of superficial knowledge. While some participants worked in collaborative teams, other teams’ responsibilities were delineated, and this impacted on how knowledge of biases was shared and acted on. Logistical and practical issues could prevent known solutions to mitigate biases being implemented. Biases also manifested because of a perception from participant recruiters that the purpose of research is for participant benefit rather than producing generalisable knowledge; and a normalisation or expectation that CRTs produce a lower level of evidence.

There is an urgent need to ensure that CRTs are free from risks of bias. Mitigation measures are either not known, not practical or unconsciously subverted. More education and collaborative working might help. Preventing subconscious bias during participant recruitment and dispelling the myth that CRTs produce lower levels of evidence would require a change in culture.

Brain and heart conditions are among the leading causes of illness and mortality in Canada. Heart failure is one of the fastest-growing cardiovascular conditions globally, with more than 100 000 Canadians diagnosed each year. Individuals with heart failure are at significantly increased risk of mental health challenges such as depression, anxiety and stress. However, healthcare services often remain siloed, treating physical and mental health separately. This complicates care for individuals with multiple chronic conditions. This multiyear study will adapt, test and accelerate changes to regional care delivery models in Eastern Ontario to optimise brain-heart health and generate knowledge to support the spread and scale of effective interventions that address community needs and priorities. We aim to: (1) identify resource gaps by mapping available services; (2) document strengths and challenges in care delivery; and (3) co-design, pilot test and evaluate an intervention developed based on the priority gap area(s) identified through objectives (1) and (2).

This community-based participatory action research study is led by a research coalition of patient and caregiver partners, care providers and leadership staff from two Ontario Health Teams. In Year 1, we will conduct asset mapping and community consultations with individuals living with heart failure, caregivers, care providers and service organisations to identify care gaps, strengths and opportunities for improvement around modifiable behavioural risk factors and brain-heart health. A scoping review will identify evidence-based strategies to address care gaps and inform the co-design of an intervention focused on supporting individuals with brain-heart interconnected conditions. In Year 2, we will co-design an intervention with community partners for implementation with clinical test sites. Year 3 will involve pilot testing the intervention and conducting outcome and process evaluations. This will inform future spread and scale of the intervention to other brain-heart conditions and new jurisdictions.

The study is approved by the Bruyère Health Research Ethics Board (M16-24-016). Findings will be disseminated through peer-reviewed publications, conference presentations and knowledge mobilisation activities such as social media, community events and local media outreach, as well as through dedicated engagement with Ontario Health partners and the Brain-Heart Interconnectome Network via retreats and collaborative forums.

Children with special needs frequently experience accidents and injuries due to motor control difficulties. The most common home accidents include falls, burns, poisoning, drowning and choking. Compared to their typically developing peers, children with special needs are at a higher risk of home accidents and emergency department visits. Falls related to balance impairments are especially common in this population. The aim of this study is to assess the effects of a virtual reality-based home accident control simulation combined with first aid training on the awareness and initial responses to home accidents of parents of children with special needs, using a single-group pre-post quasi-experimental design.

This quasi-experimental study, using a pre-test/post-test design, is planned to include 100 volunteer parents of children with special needs who are registered at a Barrier-Free Life Application and Research Centre. The parents will receive training on home accidents via virtual reality simulation, supplemented by first aid and transfer training. Data will be collected using the Descriptive Information Form and the Home Accident Awareness Questionnaire for Parents of Children with Special Needs. Children’s balance status will be assessed to determine their fall risk using the Children’s Balance Assessment Form, the Tinetti Balance and Gait Assessment and the Nintendo Wii Fit Balance Board.

Ethical approval was obtained from the Ethics Committee of Istanbul Topkapi University. The results will be disseminated through peer-reviewed journals and academic conferences.

NCT06839196 (ClinicalTrials.gov). Protocol version: 1.2; Protocol Date: 30 April 2025. All items from the WHO Trial Registration Data Set are available in the registry record.

Lymphoma is a haematologic malignancy affecting cells of the immune system. With numerous treatment options available, clinicians and patients frequently face difficulty in selecting the most appropriate therapy. Patient-reported Outcome (PRO) offers valuable patients’ insight that may support treatment differentiation. A PRO measure (PROM) is a questionnaire or survey measuring a PRO. Despite many efforts to guide the selection of PROMs in clinical trials, choosing the appropriate ones remains a challenge. This study aims to develop a pragmatic paradigm for selecting PROMs in clinical trials involving adult patients with lymphoma through the collaboration and communication between clinical investigators involved in trials and Health Economics and Outcomes Research (HEOR) scientists specialised in research methodologies.

A rapid review was conducted to identify existing PROMs for adult patients with lymphoma in clinical trials and guidelines supporting PROM selection.

PubMed, Google Scholar and websites for regulatory and health technology assessment (HTA) bodies in eight countries of interest were searched from 2009 to July 2024.

Publications with PROMs were identified for adult patients in lymphoma trials. The most relevant guidelines supporting the development of the pragmatic paradigm were selected.

The initial search and data extraction were conducted by one author. All authors participated in an in-depth review process.

We categorise 31 applicable PROMs for lymphoma into four distinct groups, streamlining the PROM selection process to facilitate effective communication among clinical investigators, HEOR scientists, patients and others. Additionally, a five-step pragmatic paradigm is developed for identifying appropriate PROM(s).

The pragmatic paradigm presents a practical approach for selecting PROM(s) in lymphoma clinical trials. An appropriate PROM should conceptually align with the treatment goals and be acceptable to regulatory and HTA bodies. Thus, lymphoma clinical trials can generate more patient-focused data, contributing to improving patients’ quality of life and advancing lymphoma care.

Knee osteoarthritis (OA) is a leading cause of disability in older adults, with health and economic impacts. Despite pharmacological advances, exercise continues to be a fundamental pillar in the management of OA, with lower limb strength training showing significant benefits. Virtual reality (VR)-based interventions have emerged as innovative tools, providing immersive environments to facilitate functional movement exercises. VR offers pain relief, improved functionality and reduced fall risks, although its efficacy in OA management requires further exploration. The main aim of the study is to assess whether a VR-based intervention provides superior improvements in pain, stiffness, physical function and movement biomechanics compared with conventional therapeutic exercise in adults aged 60 years and older with knee OA.

This is a protocol for a randomised controlled trial comparing the effects of immersive VR interventions with conventional therapeutic exercises in individuals aged 60 years and older with knee OA. Participants are allocated 1:1 to experimental (VR) and control groups. The VR intervention involves 18 supervised sessions over 8 weeks, using Meta Quest 3 goggles to perform functional movements in virtual environments. The control group follows standard therapeutic exercise protocols per Osteoarthritis Research Society International guidelines. Outcomes include OA-related symptoms, kinematic performance, pain intensity, kinesiophobia and fall risk. Secondary measures assess cybersickness, depressive symptoms, medication use and comorbidities. Assessments occur at baseline, ninth week, sixth and ^12th months. Data analysis employs intention-to-treat principles, leveraging descriptive statistics, t-tests and multiple imputations for missing data.

This study was approved by the A Coruña-Ferrol Research Ethics Committee (reference: 2023/557), under the Galician Health Service. All participants will be required to provide written informed consent prior to their inclusion in the study. Participant data will be pseudonymised and securely stored. Additionally, anonymised datasets will be deposited in open-access repositories (Zenodo).

NCT06362785.