Care (Education) and Treatment Reviews (C(E)TRs) are intended to reduce unnecessary psychiatric hospital admission and length of stay for people with intellectual disability and autistic people. The use and impact of C(E)TRs have not been systematically evaluated since their introduction in England in 2015. The aims of this study are to describe the demographic and clinical profiles of people who receive a community C(E)TR and to investigate their effects on admission, length of hospital stay and clinical and functional change.

We will conduct a retrospective cohort study using de-identified data from electronic health records derived from two large National Health Service mental health providers in London, England, including one replication site. Data will be extracted using the Clinical Record Interactive Search (CRIS) tool for all people with recorded intellectual disability and/or autism who received mental healthcare from 2015. We will identify community C(E)TR events using keyword searches. Community C(E)TRs will be examined in two ways: (1) In a community cohort, we will capture data in the 6-month periods before and after a community C(E)TR and compare this to a matched control group and (2) In a hospital cohort, we will compare groups who did and did not receive a community C(E)TR prior to their admission. We will describe the socio-demographic and clinical profiles of each group and their health service use, and compare C(E)TR and no C(E)TR groups using t-tests (or a non-parametric equivalent). The primary outcomes are admission to a psychiatric hospital (community cohort) and length of psychiatric hospital admission and clinical change (hospital cohort). Admission to psychiatric hospital will be estimated using propensity score weighting and difference-in-differences methods. Cox’s proportional hazard model will be used for length of hospital admission and repeated-measures analysis of variance (ANOVA) will be used to assess clinical change.

Use of CRIS to examine de-identified clinical data for research purposes has overarching ethical approval. This study has been granted local approval by the South London and Maudsley CRIS Oversight Committee. Findings will be disseminated in an open-access peer-reviewed academic publication, at conference presentations, and to service users and carers in accessible formats.

Sepsis and antibiotic resistance constitute a deadly synergy, causing the loss of millions of lives across the world, with their economic and developmental consequences posing a threat to global prosperity. Their impact is disproportionately felt in resource-limited settings and among vulnerable populations, especially children. A key challenge is prompt diagnosis and timely commencement of appropriate antibiotic therapies. These challenges are compounded in low-income and middle-income countries by a lack of comprehensive epidemiological data, with Nigeria being one such country for which it is lacking. Kaduna is the third largest state in Nigeria, with over 10 million inhabitants, of whom more than half are children under 14 years old. While bacterial sepsis and antimicrobial resistance (AMR) are recognised as a growing problem in the state, there are huge gaps in the current understanding of their aetiology. This project employs a cross-sectional design to investigate the clinical and haematological markers of paediatric sepsis, alongside determining the bacterial cause and prevalence of AMR at four high-turnover hospitals in Kaduna State, Nigeria. Further, whole-genome sequencing of isolated bacterial pathogens will be performed to determine the genetic features of resistance. This project represents the largest surveillance study of paediatric sepsis in Kaduna to date. Additionally, we aim to use the clinical, haematological, microbiological and genomic data to derive predictive models for sepsis causes, treatment strategies and patient outcomes.

This is a hospital-based, cross-sectional study that will recruit up to 461 children with bacterial sepsis who were admitted at the two teaching and two general hospitals in Kaduna State, Nigeria. Children presenting with features of fever, subnormal temperature and body weakness would be recruited into the study and have their blood samples collected. The blood samples will be used for culture, complete blood count, HIV and malaria testing. Accordingly, we will capture clinical presentation, haematological characteristics, causative pathogen from blood culture and patient outcomes. Nutritional status, known congenital immunosuppressive diseases, HIV infection and malaria infection will also be determined and documented. The bacterial isolates will be phenotypically characterised for AMR and genotypically following whole genome sequencing. Known and potential confounders to the outcomes of bacterial sepsis would be assessed in all participants, and adjustment for confounding would be performed using logistic regression and/or stratification±Mantel-Haenszel estimator where applicable.

Ethical approvals were granted by the University of Birmingham (ERN_2115-Jun2024), the Ahmadu Bello University Teaching Hospital (ABUTHZ/HREC/H45/2023), Barau Dikko Teaching Hospital, Kaduna (NHREC/30/11/21A) and the Kaduna State Ministry of Health (MOH/AD M/744/VOL.1/1110018). The study will be conducted using the international guidelines for good clinical practice and based on the principles of the Declaration of Helsinki. The results will be disseminated via oral and poster presentations in scientific conferences and published in peer-reviewed journal articles.

Amyotrophic lateral sclerosis (ALS) is a rapidly progressive, fatal motor neuron disease. Diagnostic delay severely impairs patient access to ALS multidisciplinary clinics, available disease-modifying medications and therapies that may prolong survival.

To investigate how patient and physician perspectives might be leveraged to promote timely ALS diagnosis, and how system-level barriers might be addressed to promote appropriate referral to ALS multidisciplinary care.

A qualitative study in Alberta, Canada, used human-centred design and interviews to map the diagnostic journeys of ALS patients and identify individual-level and system-level diagnostic barriers and opportunities.

30 semistructured interviews (10 patients; 20 physicians) were conducted. Data were inductively analysed with the aid of Miro board software. Patient and physician data were triangulated to identify key phases of the journey from symptom onset to confirmed ALS diagnosis and themes related to the diagnostic barriers and opportunities. Journey maps were created to visualise the diagnostic journey.

Patient journeys were comprised of five phases and commonly involved iterative cycles of referral and testing before an ALS diagnosis was confirmed. Four primary themes related to diagnostic barriers: difficulty recognising and responding effectively to early-stage ALS symptoms, absence of a single definitive diagnostic test, long wait times between referrals and clinical visits, and physician reluctance to pronounce an ALS diagnosis. Analysis indicated three approaches for improving diagnostic processes: increase ALS awareness; improve communication between referring physicians and physicians receiving referrals (consultants); and develop physician, diagnostic testing and multidisciplinary clinic referral forms that will guide symptom assessment and accurate referral.

Timely ALS diagnosis is challenging for patients navigating the frequently prolonged, circuitous diagnostic journey and physicians who struggle with referral pathways and the efficient diagnosis of this rare disease. Findings demonstrate the importance of increased ALS awareness and effective communication and response within referral pathways. Recommendations include strengthening the clinical approach of community-based physicians and supporting access and referral pathways. Current initiatives arising from this investigation seek to achieve meaningful change in timely referrals for progressive neurological diseases like ALS.

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.

To assess the preliminary effectiveness and cost-effectiveness of a culturally tailored, music-based broadcast intervention delivered through schools and community radio to improve referral adherence among schoolchildren to inform the need for a definitive trial.

Pilot randomised interventional study.

18 schools across Unguja and Pemba islands, Zanzibar.

Schoolchildren (6–18 years old) who failed vision screening and were referred for care recruited from January to February 2024. The registered sample size reflects the full cohort, including children and adults. This manuscript reports on the child cohort only, as per the predefined analysis plan.

Group 1 received 3 months of school-based broadcasts of culturally tailored 3–6 min songs (played three times daily on 2 days per week), followed by 3 months of community radio broadcasts of additional songs (3–6 min, aired three times daily); Group 2 received the community broadcasts during the same period as Group 1.

The primary outcome was change in referral adherence assessed at two time points: 3 months after school broadcast and 3 months after community broadcast, expressed in difference-in-difference estimates and effect sizes. Secondary outcomes included reporting of adverse events and contamination, and cost-effectiveness calculated as cost per child reached and cost per referred child accessed care in study groups and combined intervention.

374 children were referred to eye care services, including 246 in Group 1 and 128 in Group 2. Referral adherence was 69.8% in Group 1 and 42.9% in Group 2 (p=0.0006). The school broadcast phase yielded an effect size of 0.26 and a cost of US$4.65 per referred child accessing services. The community broadcast produced an effect size of 0.21, with a cost of US$0.29 per person reached. The combined intervention reached individuals at a cost of US$0.37 per person. No adverse event and contamination was reported.

A combined school and community broadcast intervention improved referral adherence in this pilot trial, with evidence of cost-effectiveness. These findings support the conduct of a fully powered definitive trial.

NCT06469697.

Mycobacteroides abscessus (MABS) is within the non-tuberculous mycobacteria family. It inhabits soil and water, exhibits multi-antibiotic resistance and causes opportunistic lung infections, which may progress to symptomatic MABS-pulmonary disease (MABS-PD) associated with substantial morbidity, increased healthcare utilisation, impaired quality of life and increased mortality. Treatment regimens for MABS-PD are highly variable, not evidence-based and involve complex, expensive drug combinations administered for prolonged periods (>12 months) with frequent adverse effects and treatment failure. There is an urgent need for safe, efficacious and cost-effective MABS-PD therapy. Here, we describe the Master Protocol for the Finding the Optimal Regimen for Mycobacteroides abscessus Treatment (FORMaT) trial. FORMaT aims to determine the most effective and best tolerated treatment for MABS-PD as defined by MABS clearance from respiratory samples with good treatment tolerance.

FORMaT is an international multicentre, adaptive platform trial evaluating treatment combinations for MABS-PD. Participants are randomised multiple times during the trial, with assessment of the primary outcome of clearance of MABS infection with good treatment tolerance. Initially, therapies recommended in international consensus guidelines are being tested. Data obtained will eliminate therapies lacking efficacy or causing unacceptable toxicity. Novel treatments can then be added and tested against previously determined optimal approaches, leading in an iterative fashion to improved microbiological clearance and health outcomes. In parallel, an Observational cohort and several integrated and discovery studies are embedded in FORMaT to identify biomarkers of MABS-PD and MABS clearance, clinical and radiographic treatment response, drug pharmacokinetics and Mycobacteroides genomics and resistome.

The FORMaT Master Protocol and related documents are approved by regulatory authorities in each participating jurisdiction and/or site. Results will be published in peer-reviewed journals and presented at scientific meetings. De-identified, aggregated data will be shared on an approved online platform.

NCT04310930, ANZCTR12618001831279, 2020-000050-10, ISRCTN67303903.

Injury is a major cause of death in Rwanda, with many deaths occurring before hospital admission. Timely transport of injured patients to appropriate hospitals is crucial, ideally within an hour for severely injured patients. However, delays in reaching treatment facilities are common, with ambulance services using inefficient mobile phone communication. This project aims to evaluate the effectiveness and implementation of an innovative electronic communication platform (912Rwanda).

The study will be conducted through the public ambulance service, Service d’Aide Médicale d’Urgence (SAMU), and receiving health facilities in Kigali city and Musanze district in Rwanda. The 912Rwanda intervention will be rolled out in the two locations at different times. The primary effectiveness outcome is the time from ambulance deployment to patient arrival at the health facility. Secondary effectiveness outcomes include disaggregated times of the primary outcome and clinical outcomes, such as length of stay and requirement for intensive care. These outcomes will be evaluated using an interrupted time series analysis, accounting for non-homogeneous variances, auto-regressive errors and non-linear trends where appropriate. Implementation outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) Qualitative Evaluation for Systematic Translation (QuEST) framework. Cost-effectiveness will be evaluated using a cost-consequence analysis with consequences as determined by the interrupted time series analysis.

Ethical approval was obtained from the Rwanda National Research Ethics Committee (Ref No: 99/RNEC/2023). Dissemination will occur through open-access peer-reviewed publications, relevant national and international conferences.

ISRCTN97674565.

Poor chest health is the leading cause of early mortality in children with cerebral palsy (CP). It is also the most common reason to seek healthcare, accruing significant costs and reducing quality-of-life for children and families. Clinical trials examining chest health interventions in CP are characterised by inconsistent outcome measures, limiting the capacity for evidence synthesis to inform clinical application. The study aims to develop a core outcome set (COS) and related measurement instruments to assess, monitor and evaluate chest health in children with CP, both in research and routine clinical practice. The COS will reflect the views of children, young people, parent/carers, clinicians and researchers, emphasising under-represented groups in research and those at risk of poorer chest health.

A 3-phase methodology will be conducted in line with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. (1) Candidate outcomes will be identified through a qualitative evidence synthesis and interviews with key stakeholders. Findings will be mapped to COMET-taxonomy, generating a list of candidate outcomes. (2) An international e-Delphi survey will invite stakeholders to rate the importance of each outcome, followed by a consensus meeting to ratify the COS. (3) A structured review, guided by health measurement taxonomy, will evaluate relevant instruments, with a final meeting to agree on recommended measures for each COS domain.

Ethical approval was provided by the University of Plymouth Research Ethics Committee for the qualitative interview study (ID5116), e-Delphi study and consensus meeting (ID5636). Study findings will be published open access in a peer-reviewed journal and presented at relevant national and international conferences.

COMET registration: 2590 (https://www.comet-initiative.org/Studies/Details/2590)

CRD42024562735.

There are currently no validated screeners that evaluate diet and lifestyle of people living with and beyond cancer (PLWBC). The purpose of this study was to reach a consensus among an international expert panel on the essential items to include in this type of instrument.

A scientific committee developed the initial list of items, which were presented to an expert panel in a two-round-modified electronic Delphi. Panellists were asked to rate the adequacy, relevance and feasibility of self-reporting each item. Qualitative assessments were encouraged.

Four countries (Spain, UK, USA and Portugal).

Experts working in a cancer-related health profession or cancer-related research were recruited.

Items were initially categorised into seven domains (body composition, physical activity, diet, alcohol, smoking, sleep and psychosocial distress). A content validity index per item (CVI-i) and a scale-level CVI (S-CVI) were calculated (acceptable≥0.78). All items with a CVI-i≥0.78 were submitted to a final consensus meeting.

A total of 108 items were proposed to the panel. In Round 1, 77 items were accepted, 10 items were excluded and 6 new items were proposed. During Round 2, 4 items were accepted and 19 were excluded. Diet and alcohol were merged into one domain. The final consensus meeting decided on 61 items categorised into six domains (S-CVI:0.94): body composition, physical activity, diet and alcohol, smoking, sleep and psychosocial distress.

We identified the main items to be considered when developing a screener to evaluate diet and lifestyle in PLWBC in a clinical setting, and the results obtained will guide the content of the screener in the following validation study.

Aphasia is a language impairment that affects one-third of people who experience a stroke. Aphasia can impact all facets of language: speaking, understanding, reading and writing. Around 60% of people with aphasia have persistent language impairments 1 year after their stroke, requiring ongoing healthcare and support. In recent years, the internet has become a key resource for the self-management of chronic health conditions. Navigating web content, however, requires language use, and as such, people living with aphasia are more likely to be excluded from digital health and support services. Web Content Accessibility Guidelines exist; however, they do not fully address the unique and diverse needs of people with aphasia, and a significant proportion of websites (over 90%) do not fully adhere to them. This protocol paper describes the first two stages of the Bridging the Digital Divide project, which aims to codesign and develop (a) a web-browser extension to re-render webpages to an ‘aphasia-friendly’ (accessible) format, (b) training tools to help users and health professionals customise the web-browser extension and (c) guidelines for developing communication-accessible websites.

The research will be conducted using experience-based codesign. In Stage 1a, focus groups will be held with (1) people with aphasia, (2) family members or significant others and (3) health professionals working with people with aphasia. Participants will be asked to share their experiences of accessing (or supporting a person with aphasia to access) healthcare, information and support services on the web. The nominal group technique (NGT) will be used to identify priorities for improving web accessibility for people with aphasia. Focus group data will be analysed using reflexive thematic analysis, and prioritisation data will be analysed using inductive qualitative content analysis. In Stage 1b, eight codesign workshops will be held with representatives of the three key stakeholder groups to iteratively codesign and develop a web-browser extension, training tools and guidelines to support web accessibility.

Ethical clearance for Stage 1a and Stage 1b of this project has been approved by the University of Queensland Human Research Ethics Committee (Stage 1a approval number: 2023/HE000528, Stage 1b approval number: 2024/HE000721). The outcomes of this research will be disseminated in peer-reviewed journals and presented at national and international conferences. A dissemination and celebration event will be held at the completion of the project.

To test associations between mental well-being across the life course and exposure to childhood physical and/or verbal abuse.

Secondary analysis of combined data from seven cross-sectional general adult population surveys measuring childhood experience of physical and/or verbal abuse and current mental well-being.

Households across England and Wales.

20 687 residents in England and Wales aged 18 years or over.

Self-reported childhood physical and verbal abuse using questions from an Adverse Childhood Experiences tool. Individual and combined components of adult mental well-being measured using the short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS).

Exposure to either childhood physical abuse or verbal abuse was associated independently with a similar significant increase in likelihood of low adult mental well-being, with exposure to both abuse types compounding increases (adjusted ORs 1.52, 1.64, 2.15 respectively, reference category: neither abuse type). Individual components of mental well-being showed similar associations, with adjusted prevalence of never or rarely having felt close to people in the last 2 weeks rising from 7.7% (neither abuse type) to 9.9% (physical abuse), 13.6% (verbal abuse) and 18.2% (both types of abuse). Within sample trends showed a significant drop in the prevalence of child physical abuse from around 20% in those born from 1950 to 1979 to 10% in those born in 2000 or after. However, verbal abuse rose from 11.9% in those born before 1950 to nearly 20% in those born in 2000 or after.

Exposure to childhood physical or verbal abuse have similar associations with lower mental well-being during adulthood. Interventions to reduce child abuse, including physical chastisement, should consider both physical and verbal abuse and their individual and combined consequences to life course health. The potential role of childhood verbal abuse in escalating levels of poor mental health among younger age groups needs greater consideration.

Scoping reviews, mapping reviews and evidence and gap maps (collectively known as ‘big picture reviews’) in health continue to gain popularity within the evidence ecosystem. These big-picture reviews are beneficial for policy-makers, guideline developers and researchers within the field of health for understanding the available evidence, characteristics, concepts and research gaps, which are often needed to support the development of policies, guidelines and practice. However, these reviews often face criticism related to poor and inconsistent methodological conduct and reporting. There is a need to understand which areas of these reviews require further methodological clarification and exploration. The aim of this project is to develop a research agenda for scoping reviews, mapping reviews and evidence and gap maps in health by identifying and prioritising specific research questions related to methodological uncertainties.

A modified e-Delphi process will be adopted. Participants (anticipated N=100) will include patients, clinicians, the public, researchers and others invested in creating a strategic research agenda for these reviews. This Delphi will be completed in four consecutive stages, including a survey collecting the methodological uncertainties for each of the big picture reviews, the development of research questions based on that survey and two further surveys and four workshops to prioritise the research questions.

This study was approved by the University of Adelaide Human Research Ethics Committee (H-2024-188). The results will be communicated through open-access peer-reviewed publications and conferences. Videos and infographics will be developed and placed on the JBI (previously Joanna Briggs Institute) Scoping Review Network webpage.

People living with multiple long-term conditions (MLTC) admitted to hospital have worse outcomes and report lower satisfaction with care. Understanding how people living with MLTC admitted to the hospital are cared for is a key step in redesigning systems to better meet their needs. This scoping review aimed to identify existing evidence regarding clinical decision-making and care pathways for people with MLTC admitted to the hospital. In addition, we described research methods used to investigate hospital care for people living with MLTC.

A scoping review methodological framework formed the basis of this review. We took a narrative approach to describe our study findings.

A search of Medline, Embase and PsycInfo electronic databases in July 2024 captured relevant literature published from 1996 to 2024.

Studies that explored care pathways and clinical decision-making for people living with MLTC or co-morbidities, studies conducted fully or primarily in secondary or tertiary care published in English Language and with full text available.

Titles and abstracts were independently screened by two authors. Extracted data included country of origin, aims, study design, any use of an analytical framework or design, type of analyses performed, setting, participant group, number of participants included, health condition(s) studied and main findings. Included studies were categorised as either: studies reviewing existing literature, studies reviewing guidance, studies utilising qualitative methods or ‘other’.

A total of 521 articles were screened, 17 of which met the inclusion criteria. We identified a range of investigative methods. Eight studies used qualitative methods (interviews or focus groups), four were guideline reviews, four were literature reviews and one was classified as ‘other’. Often, researchers choose to combine methods, gathering evidence both empirically and from reviews of existing evidence or guidelines. However, none of the empirical qualitative studies directly or solely investigated clinical decision-making when treating people living with MLTC in acute care and the emergency department. Studies identified complexities in care for people living with MLTC, and some authors attempted to make their own recommendations or draft their own guidance to counter these.

This scoping review highlights the limitations of the current evidence base, which, while diverse in methods, provides sparse insights into clinical decision-making and care pathways for people living with MLTC admitted to hospital. Further research is recommended, including reviews of guidelines and gathering insights from both healthcare professionals and people living with MLTC.

School environments that encourage children to be physically active can embed lifelong positive health behaviours and contribute towards reducing health inequalities. The Health and Activity of Pupils in the Primary Years (HAPPY) study aims to: (1) explore the extent to which the WHO criteria for creating active school environments are implemented by primary schools and (2) examine associations between active school environments and children’s physical activity, mental health and educational performance.

The HAPPY study is a quasi-experimental study comprising: (1) a survey of state-funded Greater London primary schools to identify implementation of the WHO’s six criteria and (2) a cross-sectional study to examine associations between schools’ active environment score (derived from the school survey) and pupils’ physical activity, mental health and educational performance. For our cross-sectional study, we will recruit up to 1000 year-three children (aged 7–8 years). Our primary outcome is accelerometer (GENEActiv) assessed physical activity, our secondary outcomes are parent-reported child mental health (Strengths and Difficulties Questionnaire) and teacher-reported educational performance (age-related expectations). Using multilevel mixed-effects regression models, we will examine associations between the active environment score and physical activity. Physical activity will be included as a measure of acceleration and also different intensities (light, moderate, vigorous). We will repeat this analysis to examine associations between the active environment score and mental health and educational performance. We will adjust for school characteristics and area-level deprivation and include pupil characteristics (eg, sex, ethnic group) as covariates. Clustering at the school level will be included as a random effect.

Ethical approval has been obtained from Imperial College Research Ethics Committee (ref: 6800895). Findings will be disseminated through a summary report to all participating schools, peer-reviewed publications, presentations at national and international conferences and National Institute for Health and Care Research policy briefings.

Prescribing antibiotics may reinforce patients’ beliefs that antibiotics are needed and increase future consultations for similar symptoms. This review determines the effect of antibiotic prescribing for respiratory infections in primary care on future reattendance.

A systematic review and meta-analysis of randomised controlled trials (RCTs) and cohort studies and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Participants were adults or children presenting with respiratory infection in primary care.

MEDLINE (Ovid), PubMed, Embase, the Cochrane Central Register of Controlled Trials, clinical trial registries and grey literature sources were searched from inception until 6 February 2024.

Eligible studies included open-label RCTs or cohort studies of antibiotics compared with no antibiotics in adults or children with respiratory infections. The outcome of interest was reattendance at least 28 days after the initial consultation.

Two reviewers independently screened, selected, assessed the quality and extracted data. Separate meta-analyses were presented for RCT and cohort studies and a combined meta-analysis of all studies.

We identified 2128 records and reviewed 48 full texts, of which five met the inclusion criteria. These reported three RCTs (1207 randomised to antibiotics, 672 controls) and three cohort studies (209 138 exposed to antibiotics, 46 469 controls). In the meta-analysis of RCTs, relative risk (RR) of reattendance with antibiotics was 1.10 (95% CI: 0.99 to 1.23), and in cohort studies, RR was 1.21 (95% CI: 0.94 to 1.49). An important limitation is that most studies were in UK primary care.

Evidence suggests prescribing antibiotics for acute respiratory tract infections in primary care probably modestly increases future reattendance for similar conditions. Reducing antibiotic prescribing may help decrease demand for primary care.

CRD42023470731.

International consensus guidelines support the initial administration of 30 mL/kg of intravenous fluids for haemodynamic resuscitation of newly diagnosed septic shock. Practice variation exists between the volume of fluids administered and timing of vasopressor commencement. The optimal approach in patients with septic shock is uncertain.

Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis is a 1000-participant multicentre, randomised, open-label, parallel group clinical trial conducted in patients with septic shock presenting to the emergency department in participating sites in Australia, New Zealand and Ireland. Participants are randomised (1:1) to either restricted fluids and early vasopressors or a larger initial intravenous fluid volume and later vasopressors. The primary outcome is days alive and out of hospital at day 90 postrandomisation. Secondary outcomes are all-cause mortality at day 90, time from randomisation until death (to day 90), days alive and at home at day 90 and ventilator-free, vasopressor-free and renal replacement-free days to day 28 postrandomisation and death or disability at 6-month and 12-month postrandomisation. Health-related quality of life will be assessed at day 180 and 12 months following randomisation.

The study was approved by Northern Sydney Local Health District Human Research Ethics Committee (HREC2020/ETH02874) on 21 January 2021. Patients will be enrolled under a waiver of prior consent. The patient or next-of-kin (or equivalent according to local jurisdiction) is approached at the first available opportunity and given a trial information sheet. According to local approvals, the patient or next-of-kin chooses to either continue in the trial or opt-out/decline continued participation. Results will be disseminated in peer-reviewed journals and presented at academic conferences.

NCT04569942

VALTIVE1 is a multi-centre, single-arm, non-interventional biomarker study for patients with advanced ovarian cancer. Plasma samples (Tie2 concentration) are collected to detect vascular control in tumours during standard treatment with chemotherapy and bevacizumab. This qualitative study embedded in VALTIVE1 aimed to assess the acceptability and feasibility of a potential VALTIVE2 trial. It explored the participants’ perceptions of the study and treatments and how they might feel if bevacizumab were discontinued based on the results from the biomarker test.

This qualitative study used semi-structured telephone interviews, which were analysed using deductive and inductive thematic analysis.

Cancer treatment sites in the UK.

Participants recruited to VALTIVE1 were invited to take part in qualitative interviews. 11 female participants took part from four clinical sites.

Participants reported that they experienced side effects attributed to bevacizumab, including stiffness, pain, fatigue, nose bleeds and muscle aches. Participants felt that combining chemotherapy and bevacizumab may have increased the severity of the side effects they experienced. Most participants felt that it was acceptable, if not preferable, to be allocated to a group in a future VALTIVE2 study where bevacizumab may be discontinued according to the results from the biomarker test. A clear preference of participants was to be informed of the biomarker test results, health status and treatment side effects.

A future trial should consider ensuring all participants have access to test results, as participants indicated a preference to know whether bevacizumab was working and to discontinue bevacizumab if it had not prevented tumour growth based on the biomarker results. Comprehensive and ongoing information and support regarding treatment side effects should be provided to all participants throughout their cancer pathways and trials.

NCT04523116.