Conectar
by José Manuel García-Moreno, Tyler Adams, Amber Beynon, Janine Vlaar Olthuis, Stephan U. Dombrowski, Richelle Witherspoon, Niels Wedderkopp, Jeffrey J. Hébert
BackgroundRehabilitation and behavior change interventions are commonly used after lumbar surgery to improve recovery, but their effects on physical capacity and physical activity remain unclear. This study aimed to investigate the effectiveness of rehabilitation and behavior change interventions on physical capacity and physical activity behavior in patients following lumbar surgery for degenerative disease.
MethodsEMBASE, MEDLINE, PsycINFO, and CENTRAL were searched from inception to September 2025 and reference lists were hand-searched. Randomized controlled trials assessing rehabilitation or behavior change interventions on physical capacity or physical activity behavior in adults with lumbar degenerative disc disease who underwent lumbar surgery were included. Review author pairs independently extracted data and assessed included studies. Risk of bias was assessed with the Cochrane tool, and study quality with the Grading of Recommendations Assessment, Development and Evaluation classification. Results were pooled using random-effects models and reported as standardized mean differences (SMD) with 95% confidence intervals (CI).
ResultsExercise was more effective than minimal or usual care in improving trunk extension endurance in the immediate term (SMD, 1.54; 95% CI, 0.93–2.16). Supervised exercise outperformed self-directed exercise in improving trunk extension endurance in the immediate term (SMD, 1.28; 95% CI, 0.75–1.81). Psychologically informed rehabilitation was more effective than minimal or usual care in increasing physical activity levels in the intermediate term (SMD, 0.26; 95% CI, 0.02–0.49), but not in the immediate term (SMD, 0.17; 95% CI, −0.14 to 0.49). Physical activity advice did not increase physical activity levels compared to minimal or usual care in the immediate term (SMD, 0.21; 95% CI, −0.13 to 0.55). Prehabilitation was more effective than minimal or usual care in increasing physical activity levels in the intermediate term (SMD, 0.28; 95% CI, 0.03–0.53). Certainty of evidence ranged from low to moderate.
ConclusionsFor adults with lumbar degenerative disease who underwent lumbar surgery, exercise, especially supervised programs, improved trunk extension endurance in the immediate term. Psychologically informed rehabilitation and prehabilitation increased physical activity levels in the intermediate term, while physical activity advice showed no benefit. Findings are limited by low certainty of evidence and high risk of bias.
Ear, nose and throat (ENT) conditions are highly prevalent in primary and secondary care, yet patients frequently face prolonged waits for specialist review. In England, over half of ENT patients wait beyond the NHS 18-week referral-to-treatment target. Many of these cases can be effectively managed with advice and non-surgical interventions, presenting an opportunity for remote service innovation.
This study aims to evaluate the clinical effectiveness, cost-effectiveness, acceptability and environmental sustainability of a digitally enabled remote ENT clinic model compared with traditional face-to-face pathways.
This single-centre, mixed-methods, prospective cohort study will be conducted at University Hospitals Birmingham NHS Foundation Trust. Remote clinics will use trained staff to collect diagnostic data (including endoscopic imaging and boothless hearing tests) for consultant review via secure cloud-based software. Quantitative analysis will assess patient outcomes, costs, waiting times, carbon footprint and satisfaction. Qualitative data from semi-structured interviews with patients, clinicians and managers will explore acceptability, scalability and barriers to implementation. The qualitative data will be analysed using the framework methodology, according to the non-adoption, abandonment, scale-up, spread and sustainability framework, while the strengthening the reporting of observational studies in epidemiology framework will be used to guide the reporting of quantitative data. Cost-effectiveness analyses will follow NICE guidelines, while environmental impact will be measurement will be informed by the sustainability in quality improvement framework. Recruitment will be aiming for 300 completed datasets and 30–35 interviews.
Ethical approval has been granted (IRAS 350908; REC 25/SW/0116). Findings will be disseminated via conferences, peer-reviewed journals and institutional communication channels.
To examine Australian General Practitioners’ (GPs) confidence in initiating oral anticoagulants (OACs) for patients with atrial fibrillation (AF), and their practices for monitoring treatment adherence.
Cross-sectional online survey.
GPs practising in metropolitan, regional and rural/remote locations in Australia.
1765 Australian GPs recruited through professional GP networks.
GPs’ self-reported confidence initiating OACs; practices monitoring patient adherence and persistence; and perceived barriers to adherence. Demographic data including clinical experience and geographic location were collected. 2 analyses were used to examine associations between the key outcome variables and GP location and clinical experience.
Of 1765 respondents, 83.1% had practised for >10 years and 27.6% worked in regional or rural/remote areas. Overall, only 50.2% reported high confidence initiating OACs in patients with CHA2DS2-VA score ≥2 (a cumulative stroke risk score with a score of 1 for: congestive heart failure, hypertension, diabetes, vascular disease and age 65-74 years and 2 for: stroke/transient ischaemic attack, age ≥ 75 years). Unsurprisingly, confidence was higher among GPs with >10 years experience (51.5%) compared with 5–10 years (44.9%) and
Only half of GPs reported high confidence initiating OAC treatment, and approximately a quarter do not routinely monitor medication adherence or persistence. Targeted strategies to improve confidence and align practices with guideline recommendations are required. Appropriate education should be developed targeting the specific issues underlying lack of confidence in initiating OAC and the practice of referring newly diagnosed patients to cardiology. Further research into implementing systems for monitoring and improving adherence and persistence would be worthwhile in the context of these findings.
The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was the first to show that multidomain lifestyle interventions can enhance brain health and reduce cognitive decline. However, the clinical effectiveness and delivery of the FINGER model within primary care settings remain unexplored. This paper presents the protocol for the STRONGER 60+trial, which aims to evaluate both the clinical effectiveness and real-world delivery of an adapted FINGER-based intervention in primary care.
This 6-month randomised controlled clinical effectiveness trial will be conducted in primary care and will include adults aged 60 and older with vascular or lifestyle-related risk factors for dementia. A total of 80 participants will be randomised to either a structured, supervised multidomain lifestyle intervention or a self-guided version of the same programme. The intervention includes nutritional guidance, physical exercise, cognitive training, social engagement and management of vascular and metabolic risk factors. Data will be collected at baseline, 6 months (primary endpoint) and 12 months post-randomisation. The primary outcome is the change in a composite healthy lifestyle score at 6 months. In addition, the study will explore delivery processes and stakeholder (participant and healthcare professional) perspectives using both qualitative and quantitative methods.
The study has been approved by the Swedish Ethical Review Authority (approval numbers: 2020–05785, 2021–06413-02, 2022–05454-02) and will follow the principles of the Declaration of Helsinki. Ethical procedures for informed consent, confidentiality and data management will be strictly observed. Results will be disseminated through scientific publications, conferences and targeted outreach to healthcare professionals and the general public.
To describe the leadership trajectories of graduates of a Doctor of Philosophy in Nursing Education programme in a single university in the Philippines and examine how the doctoral programme influenced these trajectories.
Qualitative design, specifically thematic narrative analysis.
A total of 10 purposively selected graduates of the programme were interviewed with the aid of videoconferencing and life-calendaring methods.
The emerging central narrative theme is transformative potential. Leadership trajectories are characterised by expanding fields of transformative potential from within to beyond their organisations. Doctoral education shapes these trajectories through curriculum-driven capacity building, beyond-curriculum capacity building and character building.
The evolving leadership trajectories of graduates of the Doctor of Philosophy in Nursing Education programme are characterised by expanding and accumulating transformative potential.
The findings can help nursing academic institutions design and improve postgraduate degrees, which will develop transformational leaders in the profession.
What problem did the study address?
This study aims to map and describe the leadership trajectories of graduates of a Doctor of Philosophy in Nursing Education programme.
What were the main findings?
The leadership trajectories of graduates are characterised by expanding and accumulating transformative potential.
Where and on whom will the research have an impact?
The findings can inform the planning, design and evaluation of doctoral nursing degree programmes in higher education institutions, as well as continuing educational programmes for nursing leaders in academic and clinical settings.
Initial findings were sent to the graduates of Doctor of Philosophy in Nursing Education programme to validate the qualitative insights as part of member checking.
by Julia Drespling, Steffen Heelemann, Selina Strathmeyer, Heike Kühn, Bianca Schwarz, Lars Mundhenk
Equine asthma is a chronic, non-infectious inflammatory disease of the lower airways in horses, classified as mild to moderate (MEA) or severe (SEA). Its pathogenesis is not fully understood and is influenced by environmental and seasonal factors. In this cross-sectional study, seasonal effects on the bronchoalveolar lavage fluid (BALF) metabolome were investigated in asthmatic and non-asthmatic horses. The metabolome of 230 BALF samples from horses across different seasons, classified as cytologically unremarkable (CUA), MEA, or SEA, was analyzed using proton nuclear magnetic resonance spectroscopy (1H-NMR). Principal component analysis was performed for each season, and metabolite profiles were statistically compared between seasons within each group. Altered metabolites were subjected to pathway enrichment analysis using the FELLA R package. Asthmatic horses showed significant seasonal changes in metabolite concentrations between warm and cold seasons, whereas only trends were observed in CUA horses. Pathway analysis indicated enrichment of cholesterol metabolism across all groups. The mTOR signaling pathway was only enriched in SEA horses. Several metabolites—including valine, taurine and carnitine —were altered during the transition from winter to spring in asthmatic horses. These findings indicate that the winter to spring transition significantly modulates the airway metabolome in asthmatic horses, particularly in SEA-affected animals.by Gift Treighcy Banda-Mtaula, Ibrahim Simiyu, Sangwani Nkhana Salimu, Stephen A. Spencer, Nateiya M. Yongolo, Marlen Chawani, Hendry Sawe, Jamie Rylance, Ben Morton, Adamson S. Muula, Eve Worall, Felix Limbani, Miriam Taegtmeyer, Rhona Mijumbi, on behalf of the Multilink consortium
Multimorbidity, the presence of multiple chronic health conditions, is a leading cause of death globally. In Malawi, chronic noncommunicable and communicable diseases such as HIV frequently co-exist, putting pressure on an under-resourced system. However, the health system is primarily structured around disease-specific [vertical] programs, which hinders person-centred care approaches to multimorbidity. Our study focuses on multimorbidity care and explores the perceptions of healthcare workers on the patient pathways and service organisation throughout the patient’s interaction with the health facilities. This cross-sectional qualitative study took an interpretivist approach. We conducted 13 days of clinical observations at Queen Elizabeth Central Hospital and Chiradzulu District Hospital. We also conducted 13 days of clinical observations and semi-structured in-depth interviews with different cadres of purposively sampled healthcare workers (n = 22) at Queen Elizabeth Central Hospital and Chiradzulu District Hospital. Through thematic analysis, we identified an understanding of the organisation of care and healthcare workers’ perspectives on the delivery of services. Findings showed both hospitals provided services for inpatients and outpatients with multimorbidity, including screening, management, prevention of secondary conditions and rehabilitation. Patient diagnosis and management for multimorbidity were often delayed due to frequent stockouts of medication and consumables necessary for diagnostic testing for NCDs at the hospital level. Some healthcare workers were not equipped with the knowledge, skills, or guidelines to manage multimorbidity. As HIV care is currently better resourced than other chronic conditions, healthcare facilities may strengthen the supply chain, healthcare workers’ training sessions and monitoring and evaluation tools to ensure NCDs are well managed, learning from HIV programmes.This multi-centre, randomised controlled trial (RCT) investigates the effects of intensive upper limb (UL) motor training on neurophysiological and functional recovery in individuals with cervical spinal cord injury (c-SCI) during the sub-acute phase. The study aims first to assess neurophysiological adaptations in the central and peripheral nervous systems and functional changes to evaluate the impact of intensive UL motor training on recovery. Second, it determines dose dimensions and their correlation with neural and functional improvements.
A total of 44 individuals with c-SCI within 13 weeks post-injury will be recruited from five rehabilitation centres in Belgium and the Netherlands. They will be randomised into an intervention group, receiving six additional hours of goal-directed UL training per week for 8 weeks, or a control group receiving standard care. Primary outcomes are changes in resting motor threshold, a proxy for corticospinal tract integrity; compound muscle action potential amplitude, indicating peripheral nerve excitability and functionality; and assessments of strength, sensory function and prehension, with the primary comparison between groups at baseline and after the intervention period. Secondary outcomes cover additional neurophysiological assessments and motor function. Dose dimensions will be quantified and related to primary and secondary outcomes.
The central medical ethics committees, METC Máxima MC (NL84212.015.23) and MEC Gent (B6702023000227), as well as local ethics committees, reviewed and approved this trial. The protocol is registered (ClinicalTrials.gov; NCT06065384). The findings of this RCT will be disseminated through articles in peer-reviewed journals and at neurological rehabilitation conferences.
Alcohol use disorder and treatment-resistant depression (TRD) often co-occur, presenting a major clinical challenge with limited effective treatments. However, ketamine produces rapid antidepressant effects and has shown promise in reducing alcohol use, and acceptance and commitment therapy (ACT) can be effective for both substance use and mood disorders. This study explores the feasibility and acceptability of combining ACT with ketamine within the framework of the Montreal Model—a structured, integrative psychedelic ketamine therapy developed for severe TRD.
This study is a single-group, open-label feasibility trial at the Centre hospitalier de l'Université de Montréal (CHUM) Neuromodulation Ketamine Clinic in Montreal, Canada. 30 participants diagnosed with both alcohol use disorder and treatment-resistant depression will receive eight weekly in-person or virtual ACT sessions in addition to six intravenous ketamine infusions. The primary outcome is feasibility, assessed through study completion and protocol adherence. Secondary outcomes include recruitment rate, tolerability, safety, data completeness and healthcare resource use. Exploratory measures will examine changes in depressive symptoms, alcohol use and quality of life using validated tools. A subset of participants will participate in semistructured qualitative interviews to explore their experiences.
This study was approved by the ethics committee of the CHUM on 14 May 2025. The results of the trial, including primary and secondary outcomes, will be published in peer-reviewed scientific journals.
Atopic dermatitis (AD) is a chronic inflammatory skin disease affecting up to 14% of the French children. Topical treatments are restrictive, leading patients to seek alternative options. Medical hypnosis may be a therapeutic approach, providing hypno-analgesia through comfort and soothing of the skin as well as anxiolysis by managing stress and boosting self-esteem. To date, only five studies have explored medical hypnosis in AD, showing promising results but limited by small sample sizes and lack of control arms. This study protocol describes the methodology for an initial evaluation of medical hypnosis within a therapeutic patient education (TPE) programme, called Hypno-DA.
The Hypno-Atopic Dermatitis (Hypno-AD) study is a prospective, monocentric, non-blinded, parallel, cluster-randomised controlled trial conducted at the University Hospital of La Reunion, France. The study commenced on 13 August 2024 and is scheduled to conclude on 13 August 2026. The primary objective is to assess the feasibility of recruiting for a medical hypnosis programme for children with mild-to-severe AD. 32 patients (aged 8–17 years) will be randomly allocated in a 1:1 ratio to receive TPE sessions combined with medical hypnosis (experimental arm) or the usual TPE sessions performed for AD without medical hypnosis (control arm). The experimental arm will employ a hypnosis-based intervention, referred to as the ‘superhero costume’ technique. Reinforcement will be provided through the practice of self-hypnosis at home, guided by listening to an audio recording provided on a Universal Serial Bus (USB) key. Secondary outcomes will be assessed at 1-month, 3-month and 6-month post-randomisation. These will include compliance with the required practice of self-hypnosis at home, rate of loss of follow-ups, patient satisfaction, effectiveness of the hypnosis programme on the control of AD (ADCT) and severity of AD (Patient-Oriented SCORing Atopic Dermatitis) and the global impression parents may have concerning the changes in their child’s AD.
Ethics approval was obtained from the Ile de France I Research and Institutional Ethics Committee (No. 2022-A01153-40). All methods were carried out in accordance with French law No. 2012-300 (5 March 2012) related to research involving humans as well as Good Clinical Practices (International Council for Harmonisation (ICH) version 4 of 9 November 2016, and the decision of 24 November 2006). Methods will conform to the Declaration of Helsinki. Informed oral consent from at least one legal guardian of each participant will be obtained in addition to oral consent from the child. Results will be published in an indexed peer-reviewed journal as well as presented and disseminated at scientific conferences.
To determine the predictors of pressure injuries among residents living in Sri Lankan nursing homes.
A prospective multi-site longitudinal cohort study design.
Semi-structured observations and chart audits were used to gather data on 17 predictors of pressure injury from a consecutive sample of 210 residents (aged ≥ 60 years old) from nine nursing homes in Sri Lanka. Data were collected at baseline and followed up every week until the study endpoint: a new pressure injury or reaching the maximum 12 weeks of data collection, from July to October 2023. Validated semi-structured data collection forms and chart audits were utilised. Binary logistic regression was used to identify the predictors of pressure injuries. Generalised linear mixed models were used to assess the association between predictors and the development of new pressure injuries.
The cumulative incidence of pressure injuries was 17.1% (36/210) during the 12 weeks. The number of medical devices and baseline pressure injuries predicted the development of new pressure injuries. Each additional medical device increased the likelihood of developing a pressure injury by 2.3-fold, and individuals with a baseline pressure injury were 2.1 times more likely to develop a new pressure injury.
Multiple medical devices and baseline pressure injuries are predictors of pressure injury in older residents living in nursing homes.
This study provides evidence of pressure injury predictors among older residents living in nursing homes. Early identification of high-risk residents with an existing pressure injury and those with multiple medical devices is important for nurses and managers at nursing homes. Accurately assessing residents' risk of a pressure injury may result in implementing various preventive strategies that may ultimately help prevent future pressure injuries.
Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) for cohort studies guidelines.
No patient or public contribution.
Identify desired training content for shift-working nurses to improve their sleep and fatigue.
A descriptive qualitative design.
We recruited night shift nurses (N = 23) to provide feedback during virtual focus groups/interviews. Data collection occurred in the U.S. between March and June 2024. Participants were presented with sleep and fatigue topics derived from the literature. Focus group/interview data were collected and transcribed. Data were analysed using a hybrid deductive-inductive manifest content analysis with an a priori coding schema based on topics shared during data collection. Data not fitting the schema, yet informing content, were analysed inductively.
Three themes aligned with literature-derived topics. Theme 1, Why We Sleep and Why Should Nurses Care, explains the importance of sleep to health. Theme 2, Sleep Practices for Nurses to Support Health and Social Relationships, describes healthy strategies to promote sleep for enhanced quality of life. Theme 3, Fatigue and Work, illustrates the significance of nurse sleep and fatigue risk mitigation to safe working conditions and patient care.
Study findings highlight night shift nurses' interest in gaining evidence-based information to promote their sleep. Sleep education and training could fill a knowledge and skills gap, not often offered in school or workplace.
Identifying themes relevant to nurses may help increase the development and availability of sleep education and training currently tailored for nurses.
Study findings describe content night shift nurses' desire for sleep and fatigue training, serving as an important first step in developing programmes most relevant to shift-working nurses. Our analysis found the findings largely align with key components workers should receive in sleep education and training and reinforced the need for employers to offer such training. This study could benefit the nursing workforce and employers who expect rested, high-functioning nurses to care for patients.
Standards for Reporting Qualitative Research.
No patient or public contribution.
Clinicaltrials.gov, NCT06105307
To synthesise the evidence on implementation strategies used to implement transitional care interventions for adult surgical patients.
Scoping review.
Medline, CINAHL and EMBASE were searched in August 2023 and updated June 2025, followed by citation searches. Studies were screened independently by two researchers, and one extracted data, another verified its accuracy. Studies about transitional care interventions for adult surgical patients were coded according to the ‘Five classes of implementation strategies’ and the ‘Patterns, Advances, Gaps, Evidence for practice and Research recommendations’ framework, to illuminate the review findings.
Based on 27 studies included in the scoping review, staff education, changes to staffing and electronic systems, and change management techniques were frequently used implementation strategies. Implementation strategies were mostly used with patients undergoing colorectal and cardiac surgery in Asia and the United States. Scale-up strategies and capacity-building initiatives for people in charge of spearheading the change initiatives were less common.
To further the field, future research could focus on capacity-building and scale-up strategies, fidelity reporting, and financial implications of implementation in a wider range of surgical populations and settings. Work is needed to effectively implement surgical transitional care interventions in real-world settings.
Our findings provide strategies for hospital leaders to adopt when implementing transitional care interventions for surgical patients.
Scoping Reviews (PRISMA-ScR) checklist.
Determined review focus, interpreted findings, and contributed to manuscript.
The Open Science Framework.
Primary biliary cholangitis (PBC) is a rare chronic cholestatic disease that despite current therapy has significant ongoing unmet needs, including risks of cirrhosis and life-impairing symptoms. The current treatment approach is a step-up model, wherein first-line therapy, ursodeoxycholic acid (UDCA), is given for a minimum of 12 months before the addition of second-line therapy is considered for non-responding patients. This ‘waiting to fail’ approach, focused on the needs of low-risk patients, allows, we postulate, a key process of biliary epithelial cell (BEC) senescence to become established, driving accelerated bile duct loss and aggressive disease. Preclinical mouse modelling has shown that early use of the farnesoid X receptor agonist obeticholic acid (OCA), currently only used as second-line therapy following UDCA failure, reverses BEC senescence, changing the clinical course of disease. Here, we describe the design of the Optimising Primary thErapy in pRimAry biliary cholangitis (OPERA) trial. The aim of OPERA is to explore a new paradigm for disease-modifying treatment of PBC: risk-informed early treatment stratification, with patients at increased risk offered UDCA and OCA combination with the goal of complete biochemical remission.
OPERA is a multicentre, randomised, double-blind, placebo-controlled trial of OCA in combination with UDCA, as first-line treatment for high-risk PBC. This is a multicentre trial in England, which will be undertaken in specialist clinics in secondary/tertiary referral centres (or as per local set up). These centres will be specialists in the area of PBC management and will manage patients from across their local region. OPERA will recruit and randomise 106 adults, within 6 months of PBC diagnosis, who are at an enhanced risk of non-response to standard first-line therapy, between either: (1) UDCA and OCA or (2) UDCA and matched placebo in a 1:1 ratio. The primary efficacy outcome measure is the percentage of participants showing normalisation of serum alkaline phosphatase and total bilirubin values at 26 weeks (disease remission).
Favourable ethical opinion was received from London – Riverside Research Ethics Committee (reference: 22/LO/0878). Potential participants will be fully informed of their rights and the benefits and harms of the trial by the research team before giving informed consent to participate in the trial. Results will be disseminated in peer-reviewed publications, at national and international conferences, in peer-reviewed journals and to participants and the public (using lay language).
by Claudia N. Spaan, Eileen Daniels, Wouter L. Smit, Ruben J. de Boer, Joana Silva, Jacqueline L. M. Vermeulen, S. Meisner, Vanesa Muncan, Riekelt H. Houtkooper, Jarom Heijmans
Reprogramming of energy metabolism is one of the hallmarks of cancer cells and mutations that modify wild type intestinal cells to colon carcinomas increases cellular energy expenditure. Mitochondria are the main site for ATP production in (cancer) cells and disrupting their function results in impaired tumor forming efficacy. The mitochondrial ribosomal proteins (MRPs) constitute the ribosome specifically in mitochondria, and as such are crucial for the translation process of the electron transport chain complex subunits. We hence aimed to explore the consequence of reduced MRP expression on adenomagensis and investigate this in a genetic mouse model with bodywide heterozygosity for Mrpl54. We show that Mrpl54 heterozygosity does not alter adenoma formation, intestinal proliferation or apoptosis in a heterozygous Apc model. Furthermore, diminished Mrpl54 expression did not decrease stemness or global parameters of metabolism in colorectal cancer cell lines.A qualitative study was conducted in Catalonia (Spain), incorporating the views and opinions of relatives, healthcare professionals and patients on what they considered a ‘good death’. This study aimed to describe barriers, facilitators and unmet needs related to the achievement of a good death.
We recruited adult patients with advanced or chronic conditions, relatives and health and social care professionals involved in end-of-life processes of care, management or strategic planning. All participants took part in a qualitative study. The study was informed by phenomenological, hermeneutical and social constructivist perspectives and included 23 in-depth interviews and three focus group discussions with a total of 31 participants. Fieldwork was conducted between February and April 2022. Data were transcribed and analysed using qualitative thematic content and discourse analysis.
Six main themes were identified, comprising 17 subthemes. Facilitators and barriers related to achieving ‘a good death’ were categorised according to whether they occurred before death or during the dying process. Key facilitators include high-quality palliative care, open communication about death and the ability to choose the place of death. Key barriers included bureaucratic delays, inadequate resources, insufficient professional training and lack of respect for patients’ preferences and wishes.
Our study highlights the need to understand factors that facilitate or hinder the achievement of a good death and the quality of the dying process. Specifically, understanding individual preferences and unmet needs, enhancing communication, increasing awareness, reducing bureaucratic barriers and ensuring adequate resources are essential to support a more dignified end-of-life experience for patients, caregivers and healthcare professionals.
A significant proportion of infants born at ≤29+6 weeks’ gestation develop lung disease during the neonatal period, thus putting them at risk of developing prematurity-associated lung disease in childhood and adulthood. After discharge from the neonatal unit, pre-existing lung disease in preterm-born infants is exacerbated by (often frequent) respiratory viral infections requiring greater health utilisation, including hospital admissions, than their term-born equivalents. Opportunities to prevent viral infections in infancy are largely limited to anti-respiratory syncytial virus (RSV) antibody prophylaxis and recently maternal RSV immunisation, but in term-born infants, trained immunity-based vaccines such as Bactek (MV130, Inmunotek, Spain) are increasingly used. Bactek provides a promising therapeutic avenue for preterm-born infants to target postdischarge respiratory viral infection in this vulnerable group of infants. The BALLOON study aims to assess this treatment in a very/extremely preterm-born population and determine if treatment with the trained immunity-based vaccine Bactek decreases the risk of unscheduled visits to healthcare professionals for lower respiratory tract infections, when compared with placebo. Included infants are born at ≤29+6 weeks’ gestation and treated daily from term-equivalent (37–43 weeks’ postmenstrual age, PMA) or from discharge, if earlier, up to 1 year of corrected age.
542 infants are being recruited prior to discharge by neonatal units in the UK. They are being randomised to receive Bactek or placebo, once daily dose of 2 sprays (each 0.1 mL) of IMP (300 Formazin Turbidity Units), from 37 to 43 weeks’ PMA or discharge if earlier up to 1 year of corrected age. The primary objective is to assess if sublingual Bactek spray decreases the risk of health professional diagnosed lower respiratory tract infections (LRTIs) (unscheduled visits to general practitioners, accident and emergency departments and hospital admissions) between enrolment and 1 year of corrected age. Secondary outcomes include the number of parent-reported, health professional-confirmed unscheduled visits for LRTIs, the time to first parent-reported, health professional-confirmed unscheduled visit for LRTI, parent-reported wheeze episodes (identification aided by WheezeScan (Omron, Japan)), parent-reported use of respiratory medications, growth (weight, length and head circumference), parent(s)/guardian(s) reported time missed from work and/or nursery time missed for the infant and volume of adverse reactions. Viruses associated with LRTIs will also be identified.
Ethics permission has been granted by the Wales Research Ethics Committee 3 (Ref 24/WA/0181), and regulatory permission by the Medicines and Healthcare Products Regulatory Agency (CTA reference 21323/0063/001-0004). The study is registered on ISRCTN (ISRCTN14019493). Findings will be disseminated via national and international peer-reviewed journals, and conferences. Oversight of the study is being provided by an Independent Data Monitoring Committee and an independent Trial Steering Committee (TSC). The Trial Management Group (TMG) meets every month.
FreshRSS 