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Protocol for the Gut Bugs in Autism Trial: a double-blind randomised placebo-controlled trial of faecal microbiome transfer for the treatment of gastrointestinal symptoms in autistic adolescents and adults

Por: Tweedie-Cullen · R. Y. · Leong · K. · Wilson · B. C. · Derraik · J. G. B. · Albert · B. B. · Monk · R. · Vatanen · T. · Creagh · C. · Depczynski · M. · Edwards · T. · Beck · K. · Thabrew · H. · O'Sullivan · J. M. · Cutfield · W. S.
Introduction

Autism (formally autism spectrum disorder) encompasses a group of complex neurodevelopmental conditions, characterised by differences in communication and social interactions. Co-occurring chronic gastrointestinal symptoms are common among autistic individuals and can adversely affect their quality of life. This study aims to evaluate the efficacy of oral encapsulated faecal microbiome transfer (FMT) in improving gastrointestinal symptoms and well-being among autistic adolescents and adults.

Methods and analysis

This double-blind, randomised, placebo-controlled trial will recruit 100 autistic adolescents and adults aged 16–45 years, who have mild to severe gastrointestinal symptoms (Gastrointestinal Symptoms Rating Scale (GSRS) score ≥2.0). We will also recruit eight healthy donors aged 18–32 years, who will undergo extensive clinical screening. Recipients will be randomised 1:1 to receive FMT or placebo, stratified by biological sex. Capsules will be administered over two consecutive days following an overnight bowel cleanse with follow-up assessments at 6, 12 and 26 weeks post-treatment. The primary outcome is GSRS score at 6 weeks. Other assessments include anthropometry, body composition, hair cortisol concentration, gut microbiome profile, urine/plasma gut-derived metabolites, plasma markers of gut inflammation/permeability and questionnaires on general well-being, sleep quality, physical activity, food diversity and treatment tolerability. Adverse events will be recorded and reviewed by an independent data monitoring committee.

Ethics and dissemination

Ethics approval for the study was granted by the Central Health and Disability Ethics Committee on 24 August 2021 (reference number: 21/CEN/211). Results will be published in peer-reviewed journals and presented to both scientific and consumer group audiences.

Trial registration number

ACTRN12622000015741.

Community health navigator-assisted transition of care from hospital to community: protocol for a randomised controlled trial

Por: Parker · S. M. · Aslani · P. · Harris-Roxas · B. · Wright · M. C. · Barr · M. · Doolan-Noble · F. · Javanparast · S. · Sharma · A. · Osborne · R. H. · Cullen · J. · Harris · E. · Haigh · F. · Harris · M.
Introduction

The objective of this parallel group, randomised controlled trial is to evaluate a community health navigator (CHN) intervention provided to patients aged over 40 years and living with chronic health conditions to transition from hospital inpatient care to their homes. Unplanned hospital readmissions are costly for the health system and negatively impact patients.

Methods and analysis

Patients are randomised post hospital discharge to the CHN intervention or usual care. A comparison of outcomes between intervention and control groups will use multivariate regression techniques that adjust for age, sex and any independent variables that are significantly different between the two groups, using multiple imputation for missing values. Time-to-event analysis will examine the relationship between seeing a CHN following discharge from the index hospitalisation and reduced rehospitalisations in the subsequent 60 days and 6 months. Secondary outcomes include medication adherence, health literacy, quality of life, experience of healthcare and health service use (including the cost of care). We will also conduct a qualitative assessment of the implementation of the navigator role from the viewpoint of stakeholders including patients, health professionals and the navigators themselves.

Ethics approval

Ethics approval was obtained from the Research Ethics and Governance Office, Sydney Local Health District, on 21 January 2022 (Protocol no. X21-0438 and 2021/ETH12171). The findings of the trial will be disseminated through peer-reviewed journals and national and international conference presentations. Data will be deposited in an institutional data repository at the end of the trial. This is subject to Ethics Committee approval, and the metadata will be made available on request.

Trial registration number

Australian New Zealand Clinical Trials Registry (ACTRN 12622000659707).

Article Summary

The objective of this trial is to evaluate a CHN intervention provided to patients aged over 40 years and living with chronic health conditions to transition from hospital inpatient care to their homes.

A survey of what legal populations believe and know about inattentional blindness and visual detection

by Hayley J. Cullen, Helen M. Paterson, Timothy S. Dutton, Celine van Golde

Inattentional blindness refers to when people fail to notice obvious and unexpected events when their attention is elsewhere. Existing research suggests that inattentional blindness is a poorly understood concept that violates the beliefs that are commonly held by the public about vision and attention. Given that legal cases may involve individuals who may have experienced inattentional blindness, it is important to understand the beliefs legal populations and members of the community have about inattentional blindness, and their general familiarity and experience with the concept. Australian police officers (n = 94) and lawyers (n = 98), along with psychology students (n = 99) and community members (n = 100) completed a survey where they: a) stated whether an individual would have noticed an event in six legal vignettes, b) rated whether factors would make an individual more, less, or just as likely to notice an unexpected event, c) reported their familiarity with and personal experiences of inattentional blindness, and d) indicated whether they believed individuals could make themselves more likely to notice unexpected events. Respondents in all populations frequently responded “yes” to detecting the unexpected event in most legal vignettes. They also held misconceptions about some factors (expertise and threat) that would influence the noticing of unexpected events. Additionally, personal experiences with inattentional blindness were commonly reported. Finally, respondents provided strategies for what individuals can do to make themselves more likely to notice of unexpected events, despite a lack of evidence to support them. Overall, these findings provide direction for where education and training could be targeted to address misconceptions about inattentional blindness held by legal populations, which may lead to improved decision-making in legal settings.

Shaping care home COVID-19 testing policy: a protocol for a pragmatic cluster randomised controlled trial of asymptomatic testing compared with standard care in care home staff (VIVALDI-CT)

Por: Adams · N. · Stirrup · O. · Blackstone · J. · Krutikov · M. · Cassell · J. A. · Cadar · D. · Henderson · C. · Knapp · M. · Gosce · L. · Leiser · R. · Regan · M. · Cullen-Stephenson · I. · Fenner · R. · Verma · A. · Gordon · A. · Hopkins · S. · Copas · A. · Freemantle · N. · Flowers · P. · Sh
Introduction

Care home residents have experienced significant morbidity, mortality and disruption following outbreaks of SARS-CoV-2. Regular SARS-CoV-2 testing of care home staff was introduced to reduce transmission of infection, but it is unclear whether this remains beneficial. This trial aims to investigate whether use of regular asymptomatic staff testing, alongside funding to reimburse sick pay for those who test positive and meet costs of employing agency staff, is a feasible and effective strategy to reduce COVID-19 impact in care homes.

Methods and analysis

The VIVALDI-Clinical Trial is a multicentre, open-label, cluster randomised controlled, phase III/IV superiority trial in up to 280 residential and/or nursing homes in England providing care to adults aged >65 years. All regular and agency staff will be enrolled, excepting those who opt out. Homes will be randomised to the intervention arm (twice weekly asymptomatic staff testing for SARS-CoV-2) or the control arm (current national testing guidance). Staff who test positive for SARS-CoV-2 will self-isolate and receive sick pay. Care providers will be reimbursed for costs associated with employing temporary staff to backfill for absence arising directly from the trial.

The trial will be delivered by a multidisciplinary research team through a series of five work packages.

The primary outcome is the incidence of COVID-19-related hospital admissions in residents. Secondary outcomes include the number and duration of outbreaks and home closures. Health economic and modelling analyses will investigate the cost-effectiveness and cost consequences of the testing intervention. A process evaluation using qualitative interviews will be conducted to understand intervention roll out and identify areas for optimisation to inform future intervention scale-up, should the testing approach prove effective and cost-effective. Stakeholder engagement will be undertaken to enable the sector to plan for results and their implications and to coproduce recommendations on the use of testing for policy-makers.

Ethics and dissemination

The study has been approved by the London—Bromley Research Ethics Committee (reference number 22/LO/0846) and the Health Research Authority (22/CAG/0165). The results of the trial will be disseminated regardless of the direction of effect. The publication of the results will comply with a trial-specific publication policy and will include submission to open access journals. A lay summary of the results will also be produced to disseminate the results to participants.

Trial registration number

ISRCTN13296529.

Ukraine Trauma Project: the feasibility of introducing advanced trauma-care skills to frontline emergency medical services responders

Por: Bury · G. · Fitzpatrick · C. · Heron · B. · Cullen · W. · Scully · E. · Kachurets · K. · Zacharchenko · L.
Objectives

To design, develop, deliver and assess a training initiative on haemorrhage control for emergency medical services (EMS) staff in Ukraine, in an active wartime setting.

Design

Using the Medical Research Council framework for complex interventions, a training programme was designed and developed in a collaboration between Irish and Ukrainian colleagues and delivered by experienced prehospital clinicians/educators. Feedback was gathered from participants.

Setting

The Russian invasion of Ukraine has caused large numbers of trauma patients with limited access to advanced prehospital emergency care. Ukrainian authorities requested support in delivering such care.

Participants

Ukrainian EMS nominated clinical staff as trainees, in partnership with an educational institution in Kyiv.

Intervention

One day provider and train-the-trainer courses were developed and delivered, focused on early delivery of tranexamic acid (TXA), using intraosseous access (IO) in victims of wartime trauma.

Outcome measures

Safe organisation and delivery of courses, assessed knowledge and skills competence and self-reported satisfaction and pre/post confidence/competence.

Results

Two provider and one train-the-trainer courses and four equipment supply exercises were delivered for 89 EMS staff (doctors, nurses, paramedics); none had prior experience of IO or prehospital delivery of TXA. All participants were assessed as competent as providers and/or trainers. High levels of satisfaction and significantly improved self-assessed confidence and competence were reported.

Conclusion

Rapid design and delivery of a training programme focused on an identified need for advanced care of trauma patients in a wartime setting has been possible. Training and immediate access to appropriate equipment was demonstrated. Evidence of frequency of use and safe, effective interventions has not been collected; such data are important for evaluation but difficult to collect in this setting. A high level of demand for this training now exists.

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