Fetal alcohol spectrum disorder (FASD) is a diagnostic term that describes the neurodevelopmental and physical effects resulting from prenatal exposure to alcohol. Individuals living with FASD can experience lifelong challenges, yet with a diagnosis and sufficient support for the individual and their whānau (families), people can live fulfilling lives. Currently, little is known of the prevalence and impact in Aotearoa, New Zealand (NZ). Our aim is to identify the prevalence and understand the needs of young people living with FASD and other neurodevelopmental disorders in Youth Justice (YJ) residences in Aotearoa, NZ. One study will investigate the prevalence of FASD in this setting. The outcomes of both studies may demonstrate barriers and enablers, as well as strengths and gaps in YJ services of Aotearoa, NZ. The outcomes of both studies may guide reinforcing of current best practices as well as highlight necessary and novel initiatives together providing best support for the children and adolescents and their whānau as well as staff across YJ residences.

Extensive consultation with Māori and Pacific Advisory groups, researchers and experts in FASD and justice settings, individuals living with FASD and YJ staff together informed the development of this study.

Children and adolescents (hereafter young people) aged 10 to 18 years and currently residing in YJ residences are eligible for participation and assessment for FASD through assenting and consenting to provide personal and social histories and completed physical and neuropsychological assessments. The comprehensive FASD histories, screening and assessment will be conducted by a neuropsychologist and paediatrician employing standardised assessment practices and instruments. The team will also collect information from health, education and care and protection records; from the young people themselves; and from their family and staff. The study will reference Whakakotahitanga, the newly released (2024) guidelines for screening and diagnosing FASD in Aotearoa, NZ while also acknowledging the differences imposed under constraints of funding research including, for example, time and money. An individualised report will be prepared for each young person and their whānau. Study data will be analysed with descriptive statistics as appropriate. Our findings will be considered by the Māori and Pasifika advisory groups for framing and culturally secure translation, disseminated with all participating young people, translated to YJ services and staff, government and community neurodiversity sectors. Outcomes will be made available through community hubs, conferences, reports and peer-reviewed journal publications.

The study has received ethical approval from the Southern Health and Disability Ethics Committee (2024 Full 20065). Locality ethical approval has been granted from Oranga Tamariki (Ministry of Children), and a privacy impact evaluation has been undertaken. The findings will be shared through peer-reviewed publication, local and national conferences and with key agencies including Oranga Tamariki.

Administering supplemental oxygen to prevent hypoxaemia is a fundamental treatment for patients hospitalised with acute injury or illness. However, the amount of oxygen administered frequently exceeds that needed to maintain normoxaemia, causing patients to experience hyperoxaemia and wasting supplemental oxygen. Closed-loop, autonomous oxygen titration systems are designed to optimise oxygen delivery by administering the lowest possible oxygen flow that maintains peripheral oxygen saturation (SpO₂) within a predefined range. For adults hospitalised with an acute injury or illness, it remains uncertain whether the use of a closed-loop, autonomous oxygen titration system safely increases the proportion of time spent in normoxaemia (SpO₂ 90%–96%) compared with usual care.

The Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention trial is a multicentre, unblinded, parallel-group, randomised trial being conducted at four level 1 trauma centres in the USA. The trial compares an autonomous oxygen titration system versus usual care among 300 adults hospitalised for major trauma, burn, acute care surgery or acute respiratory illness. The primary outcome is the proportion of patient-time spent within the targeted normoxaemia range (SpO₂ 90%–96%) as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomisation. Secondary outcomes include the amount of supplemental oxygen administered and the proportion of time spent in hypoxaemia (SpO₂2 >96%). Specifying the protocol and statistical analysis plan before the conclusion of enrolment increases the rigour, reproducibility and interpretability of the trial. Enrolment began on 6 May 2024.

The trial protocol was approved by the single institutional review board at the University of Colorado School of Medicine and the Office of Human Research Oversight at the Department of Defense. We will present the results at scientific conferences and submit them for publication in a peer-reviewed journal.

NCT06374225.

Visual Hallucinations (VHs) (seeing things that others do not, or visions) are a common feature of psychosis, causing significant distress and disability. Services rarely ask about these important experiences, and crucially there are no proven beneficial psychological treatments. There are at least two key challenges faced when treating VHs. First, people report not knowing why they see things others don’t, which leads them to feel alone and different from others. Second, they feel they cannot trust their own eyes to tell what is real or not, which can lead to fears they will be hurt or harmed by the VH, or even if they know the experience is not real, they may fear that they are losing their mind, or that they are not able to control or manage their experiences. For these reasons, they may struggle to put skills and strategies into practice when in the presence of the VH. Consequently, we have developed a novel treatment that addresses these core issues. First, we have a psycho-education and coping strategies package called Visual Unusual Sensory Experiences (VUSE) that uses the best aspects of digital technology (animations, videos) to explain why people have VHs and provides normalising information to help the person to feel less alone. It introduces coping strategies that are then tested in Virtual Reality sessions (VR for Visions VRV) where a representation of the visual experience is provided, enabling the person to safely develop skills and gain a sense of mastery and empowerment. We now plan to test this approach in a proof-of-concept study to help determine if this will help people use these skills in the real world and so help reduce distress, improve functioning and quality of life. We will address uncertainties in the feasibility of developing and delivering this treatment and inform its future use in a larger trial.

The study is a single arm feasibility trial (n=16) evaluating VUSE+VRV and treatment as usual. The study is recruiting people with psychosis and distressing VHs in one NHS Trust and uses independent but non-blind research assistants to undertake assessments before, during and after treatment (at baseline, 6, 12 week) and at follow-up (16 weeks). Quantitative information on recruitment rates, adherence and completion of outcome assessments (VHs, other psychiatric symptoms, quality of life and perceived recovery) will be collected. Qualitative interviews will capture service-users’ experience of therapy. Analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention.

The trial has received NHS Ethical and Health Research Authority approval (25/EM/0077). Informed consent will be obtained from all participants. Findings will be disseminated directly to participants, and services as well as through open access peer-reviewed publication(s).

ISRCTN11350954.

There is substantial literature on opioid pharmacotherapies from a service user perspective, mostly focused on methadone and buprenorphine. However, as a relatively new formulation, much less is known about user experiences and views of Long-Acting Injectable Buprenorphine (LAIB). To date, no published reviews have qualitatively described LAIB service user experience. The objective of this scoping review is to identify and describe the peer-reviewed qualitative studies examining the service user experience of LAIB.

This scoping review will follow the methodology described by Arksey and O’Malley, further adapted by Levac et al and others. The search strategy will be developed in collaboration with an expert librarian and will include searches of Medline, Embase, PsycINFO, CINAHL, Scopus and Web of Science as well as citation chaining. The search dates will range from 2016, when LAIB was first approved, to the date of the final search. Included studies will investigate the perspectives and experiences of LAIB treatment participants with opioid dependence, within an Opioid Treatment Programme (OTP). For service users, the pharmacological formulation of LAIB significantly reshapes both the clinical practice and the social dynamics within OTPs. To effectively capture the depth and nuance of service users’ experiences, this review will be limited to qualitative, mixed-method, case series or case study designs, with a further restriction to peer-reviewed articles published in English. Identified references, with duplicates removed, will be imported into Covidence for title/abstract screening, full-text review and data extraction by two independent reviewers. All decisions on data inclusion or exclusion will be by consensus agreement, using a third reviewer if necessary. A living experience researcher will lead analysis of manuscript content in NVivo using inductive coding to produce a descriptive thematic analysis. The narrative summary will present key study characteristics, quality appraisal and synthesised findings that describe service user experiences and perspectives of LAIB, guided by the Systematic Reviews and Meta-Analysis for Scoping Reviews checklist.

This scoping review undertakes secondary analysis of data in the public domains only and thus does not require ethics approval given no participants are directly involved. The results of the review will be published in a peer-reviewed journal, presented at relevant academic and community conferences, and discussed and disseminated to/with community organisations, service users and policy-makers.

Prepublication history and additional supplemental material for this paper are available online. To view these files, visit: Open Science Framework https://doi.org/10.17605/OSF.IO/XMHKN.

Approximately, 20 million older adults undergo major elective surgery annually, yet less than 10% engage in advance care planning (ACP). This is a critical missed opportunity to optimally engage in patient-aligned medical decisions and communications in the perioperative setting. The PREPARE ACP programme (easy-to-read advance directives (ADs) and a patient-directed, online ACP programme) has been shown to increase ACP documentation and patient and clinician empowerment to discuss ACP. Yet, a gap remains in extending PREPARE’s use to surgical populations. We hypothesise that by delivering PREPARE in a patient-facing electronic health record (EHR) centric presurgery workflow for older adults, supported by automated patient reminders and outreach from a healthcare navigator (HCN), we can enable patients and/or surgical teams to engage in ACP discussions.

This is a three-site, single-blinded, pragmatic randomised trial comparing increasing intensity of ACP-focused, patient-facing EHR messaging and HCN support. The outreach occurs prior to a new presurgical clinic visit. We will enrol 6000 patients (2000 each site) aged 65 and older and randomise them equally to the following study arms: (Arm 1) ACP-related cover letter and PREPARE URL information sent via patient portal and postal mail (includes cover letter, AD and PREPARE pamphlet); (Arm 2) Arm 1 plus reminder message via text or MyChart message and (Arm 3) Arm 2 plus HCN outreach and support. The primary outcome is clinically meaningful ACP documentation in the EHR (ie, surrogate designation, documented discussions and ADs) within 6 months of the new surgical visit. The rate of ACP documentation will be compared between treatment groups using generalised estimating equations. Secondary outcomes include a validated four-item ACP engagement survey, administered 2 weeks after the presurgical visit and 6 months later. All analyses will follow the intention-to-treat principle and recent Consolidated Standards of Reporting Trials guidelines.

The study will be conducted according to the Declaration of Helsinki, Protection of Human Volunteers (21 Code of Federal Regulations (CFR) 50), Institutional Review Boards (21 CFR 56) and Obligations of Clinical Investigators (21 CFR 312). The protocol and consent form were reviewed and approved by Advarra, an National Insitutes of Health (NIH)-approved, commercial, centralised Institutional Review Board (IRB). The IRB/Independent Ethics Committee of each participating centre reviewed and approved the protocol and consent and obtained reliance agreements with Advarra prior to study initiation. The study is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of the study will be disseminated to both academic and community stakeholders, complying with all applicable privacy laws.

ClinicalTrials.gov ID: NCT06090552.

Advarra Pro 00070994.

23-38948.

Protocol Date: 24 October 2024. Protocol Version: 4.