Acute respiratory distress syndrome (ARDS) is a major public health problem, accounting for 23% of intubated patients and associated with high mortality rates. Although lifesaving, invasive mechanical ventilation can worsen lung injury when ventilator settings are poorly adjusted to lung physiology. We hypothesise that individualising ventilator settings via (1) the bedside assessment of lung recruitability using a one-breath derecruitment manoeuvre and measurement of airway opening pressure to set positive end-expiratory pressure (PEEP), (2) controlling the distending pressure and (3) controlling respiratory drive improves ARDS outcomes.

The CAreful Ventilation In ARDS trial is an investigator-led multicentre (33 centres in eight countries), open-label, randomised controlled basket trial comparing two ventilation strategies in two subpopulations of moderate-to-severe ARDS: induced or not by COVID-19. A total of 740 patients will be randomised (370 in each substudy) in a 1:1 ratio to individualised ventilator settings or to using traditional PEEP to inspired fraction of oxygen tables for PEEP setting. Indications for proning and weaning strategies are similar in both arms. The primary outcome is all-cause mortality at day 60. Secondary outcomes include duration of mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, organ dysfunction, barotrauma and mortality in ICU, at day 28 and in hospital.

Ethics approval has been obtained for all participating centres: Unity Health Toronto Research Ethics Board (for three centres: St Michael’s Hospital, Toronto General Hospital and Toronto Western Hospital); Comité de Ética de Investigación con Medicamentos del Hospital Universitari Vall d’Hebron; Comité de protection des personnes Ile de France III; Comité d'Ética de la Investigatción con Medicamentos de la Fundació de Gestió Sanitària del Hospital de la Santa Creu i Sant Pau; Comitato Etico—Fondazione Policlinico Gemelli; Comitato Etico di Area Vasta Emilia Centro; NYU Langone Health Institutional Review Board; Comité Ético Científico de Ciencias de la Salud; Il Comitato Etico Area 1 dell’Azienda Ospedaliero-Universitaria ‘Ospedali Riuniti’ di Foggia; HIGA ‘Eva Perón’ Comité de Bioética; Comité de Revisión Institucional del Hospital Británico Comité de Ética en Investigación; Complejo Médico Churruca-Visca Comité de Ética Biomédica; Comité de Ética SATI Comité de Ética en Investigación; Comité de Ética en Investigación del CEMIC; Comité de Ética SATI Comité de Ética en Investigación; Medical Research Ethics Committees United. Findings will be disseminated in peer review journals and conference presentations.

NCT03963622.

The management of active patients with symptomatic knee osteoarthritis (KnOA) who are too young for total knee arthroplasty poses a specific challenge to clinicians. Research studies show that improving quadriceps muscle strength improves pain and function; however, aspects of the disease render it difficult for patients to achieve and maintain improvements. Recombinant human growth hormone (rHGH) is shown to increase the magnitude and duration of muscle growth when combined with exercise treatment in adult populations. Hence, rHGH combined with physical therapy may provide meaningful benefits in the treatment of KnOA.

This is a single-centre, double-blind, randomised trial to pilot a future Phase III trial from 2025 to 2028. Participants are aged 18–60 with clinical and radiographic evidence of isolated degenerative arthritis of the knee (patellofemoral or tibiofemoral). The investigational product is rHGH (Saizen (somatropin of rDNA origin, EMD Serono)) and a saline placebo. Participants will deliver the solution via subcutaneous injection area once per day at a dose of 0.5 mg HGH per body surface area (0.5 mg/m²) for 6 weeks, alongside participation in a lower limb strengthening programme developed by rehabilitation specialists. 17 participants will be recruited into each study arm.

The primary outcomes are feasibility (compliance with the study drug regimen for the 6-week administration period and enrolment rate) and safety (the proportion of minor and major adverse events between groups). The primary endpoint for these outcomes will be at 6 weeks. The secondary outcomes are knee extension strength, knee flexion strength, radiographic arthritis progression, thigh muscle circumference, MRI-measured quadriceps muscle volume and patient-reported outcome measures (Knee Osteoarthritis Outcome Score (KOOS), SF-20 and Tegner). The primary endpoint for these outcomes will be at 12 weeks, and the final endpoint will be 24 months, where final radiographic (X-ray) assessment will take place.

The primary outcome of compliance will be a calculation of mean compliance between groups, which can be analysed as a t-test after the treatment period. A two-sample, two-sided t-test will compare the clinical (secondary) outcome of greatest interest: knee extension strength at baseline versus week 6 compared between treatment groups. Other secondary outcomes will be compared using a simple linear mixed-effects model. The ² test will be used to determine whether the number of participants who made meaningful changes was different between groups. The null hypotheses are that the rHGH and placebo groups will have no difference in compliance rates, safety events, knee extension strength at 12 weeks and arthritis grade progression at 24 months.

This study has been approved by the Sunnybrook Research Institute Research and Ethics Board (#6427) and received a no-objection letter from Health Canada Clinical Trials. The primary sponsor is the Sunnybrook Centre for Clinical Trial Studies (CCTS). The findings of this study will be published in a peer-reviewed journal and presented at orthopaedic conferences.

NCT07036003.

Poor cardiopulmonary fitness is an important risk factor for postoperative complications, yet a feasible, objective and prognostically accurate method to assess preoperative fitness has not been established. The 6 min walk test (6MWT) is a simple, inexpensive and widely applicable measure that shows promise for predicting postoperative risk. However, robust data are lacking on whether the 6MWT accurately predicts complications, provides incremental prognostic value beyond routinely collected clinical factors or outperforms simpler alternatives such as questionnaires, cardiac biomarkers or grip strength testing. The Functional Assessment for Surgery by a Timed Walk (FAST Walk) study is designed to address these knowledge gaps by evaluating whether the 6MWT improves prediction of key postoperative outcomes compared with clinical factors and simpler measures of fitness.

The FAST Walk study is an international multicentre prospective cohort study of 1672 adults (≥40 years) undergoing major elective non-cardiac surgery at centres in Canada, Hong Kong, Australia, Spain and the Netherlands. Participants complete a preoperative 6MWT and baseline assessments of comorbidities, self-reported cardiopulmonary fitness (MET: Re-evaluation for Perioperative Cardiac Risk questionnaire), biomarkers (N-terminal pro-B-type natriuretic peptide) and grip strength. The primary outcome is 30-day death or major postoperative complication, defined as Clavien-Dindo grade II or higher. Secondary outcomes are (1) death or new significant disability at 90 days after surgery and (2) days alive and out of hospital at 30 days after surgery. Disability is measured using the short-form WHO Disability Assessment Schedule 2.0 instrument. Multivariable regression models and complementary metrics of prediction performance will be used to determine whether 6MWT distance adds prognostic value beyond routinely collected clinical factors and simpler measures of fitness.

The FAST Walk study has received research ethics board approval at all participating sites. Recruitment commenced in June 2024, with completion of participant follow-up expected in 2026. Findings will be disseminated through peer-reviewed publications and conference presentations, with the primary results anticipated in 2027.

NCT06412367.

To evaluate the association between cumulative radiation dose and haematological parameters among radiation workers and compare the prevalences of abnormalities in blood counts with those in the general population.

Retrospective cohort study.

Nationwide radiation dose registry in Korea, linked with occupational health examination data. Cumulative doses were estimated using annual personal dose equivalent (H_p(10)) records from 1984 onward.

The study included 20 414 radiation workers, comprising 17 651 men (86.5%) and 2763 women (13.5%), with baseline survey data, dosimetry records and at least one complete blood count (CBC) record between 2014 and 2019.

The primary outcome was the continuous haematological parameters, including white blood cell (WBC), platelet (PLT) and haemoglobin (Hb) counts, in relation to cumulative radiation dose. Associations were evaluated using linear mixed-effects models incorporating repeated measurements and adjusting for age, smoking status and body mass index. The secondary outcome was the prevalence of abnormal blood counts among radiation workers.

Most haematological parameters among radiation workers were within normal ranges. In male workers, cumulative radiation dose was associated with increased Hb levels (β=0.5 mg/dL per 1 mSv; 95% CI 0.006 to 0.9) after adjusting for age, smoking status and body mass index. No significant associations were observed between cumulative dose and WBC or PLT counts in either sex. Overall, compared with the general population, radiation workers had significantly lower standardised prevalence ratios for abnormal WBC and PLT counts.

No substantial adverse changes in haematological parameters were found among radiation workers exposed to prolonged low-dose radiation. The findings suggest that cumulative doses at occupational levels may not substantially affect CBC profiles, although continued monitoring and follow-up are warranted.

We conducted a pilot randomised controlled trial (the PHaCT study), including a process evaluation to assess the acceptability of a housing-led Critical Time Intervention (CTI) for prison leavers and the use of a trial design. This paper presents the process evaluation findings.

To explore the acceptability of both the intervention and the trial design to participants and those delivering the intervention, and to assess whether the intervention was delivered with fidelity.

A process evaluation following Medical Research Council guidelines. Data collection included semi-structured interviews with participants and CTI caseworkers and observations of intervention delivery. A thematic analysis of interviews and observations was conducted to understand the intervention’s implementation and contextual factors as well as the trial process acceptability.

Participants for the pilot trial were recruited from three prisons in England and Wales where the intervention was being delivered.

While 28 out of 34 trial participants consented to interviews, only one was completed. Seven caseworkers were interviewed.

A housing-led CTI to support people leaving prison at risk of homelessness, involving phased, time-limited support from caseworkers, starting prerelease and continuing postrelease, to help secure stable housing and build independence, without directly providing housing.

The intervention’s acceptability was primarily reflected through the positive feedback and success stories shared by CTI caseworkers, as well as observational data indicating high acceptance among service users. The trial design’s acceptability was challenged by concerns about randomisation and equipoise, with staff viewing randomisation as unethical due to limited support for vulnerable populations. The fidelity to the CTI intervention housing-led approach was adhered to as best as possible; stable housing was prioritised for service users before addressing other needs. Despite these efforts, both sites encountered significant challenges due to limited housing availability and complex systems for securing social housing, particularly for single men leaving prison.

This wider study faced significant challenges which impacted the process evaluation. Despite these issues, the evaluation provides important insights into the challenges of conducting trials on interventions for people leaving prison. The challenges experienced should inform future study designs with similar populations and in similar settings.

ISRCTN46969988.

To determine whether a full-scale randomised control trial (RCT) assessing the efficacy and cost-effectiveness of a housing led Critical Time Intervention (CTI) is feasible and acceptable.

Pilot parallel two-arm individual level RCT, including process evaluation and embedded exploratory health economic evaluation.

Four prisons for men across England and Wales, UK.

Men leaving prison at risk of homelessness and intervention delivery staff.

CTI has four components: (1) pre-engagement phase: assessing the needs of the client and implementing a plan pre-discharge; (2) transition to community: forming relationships and goal setting; (3) try out: encouraging problem-solving and managing practical issues and (4) transfer of care: developing long-term goals and transferring responsibilities to community providers.

Progression criteria: recruitment, retention, acceptability of the processes (CTI and trial method) and fidelity of intervention delivery. We also assessed the completeness of primary, secondary and exploratory outcome measures and estimated intervention costs.

The recruitment progression criterion was met, with 92% (34/37) of approached individuals consenting to participate (target: 50%). However, the overall recruitment target of 80 was not achieved, and retention was low, only 18% (6/34) provided follow-up data, well below the 60% threshold. Retention was hindered by systemic challenges, including changes to prison release policies and reduced probation support. While the CTI model was acceptable to staff and service users, the trial design, particularly randomisation, was not. Intervention fidelity met the progression criteria. Baseline data collection for health economics and resource use was feasible, and intervention costs were estimated.

This pilot trial identified significant challenges to conducting a full-scale RCT of CTI in this context, particularly around retention, trial acceptability and systemic instability. While CTI remains a promising model, a traditional RCT design may not be viable in this setting without substantial structural and ethical adaptations.

ISRCTN46969988.

Cardiovascular diseases (CVDs) are the leading cause of death worldwide, making the development of self-management strategies crucial for preventing complications and improving clinical outcomes. This process involves symptom monitoring, treatment adherence, emotional management and a healthy lifestyle, among others. Reliable instruments are necessary to measure self-management, requiring robust psychometric properties. In this way, this COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)-based systematic review aims to assess the quality of specific self-management instruments for adults with CVDs.

This systematic review will follow the COSMIN and be reported according to the Preferred Reporting Items for Systematic Review and Meta-analysis Protocol. Searches will be conducted in seven databases: MEDLINE, Web of Science, Scopus, PsycINFO, EMBASE and CINAHL. Additionally, a manual search will be performed on PROQOLID, PROMIS and The Medical Outcome Trust websites. Studies on the development and validation of patient-reported instruments measuring specific self-management for individuals with CVDs will be included, without language or date restrictions. The search will be performed in November 2025, with the final version of the review expected to be completed in October 2026. Data extraction will follow COSMIN recommendations. The Modified Grading of Recommendations, Assessment, Development and Evaluation approach will be used to determine the quality of evidence. Instruments will be categorised according to COSMIN recommendations. All steps will be conducted by two independent reviewers, with a third reviewer involved in case of discrepancies. Additionally, the content of the instruments will be analysed and linked to the International Classification of Functioning, Disability and Health, following international recommendations.

This study does not require ethics committee approval as it is a review of published data. The review results will be disseminated through peer-reviewed journal publications and presentations at scientific conferences.

CRD42024605969.

Telerehabilitation (TR) programmes are increasingly recognised for their feasibility and potential benefits, such as eliminating travel time, reducing costs and providing a more comfortable rehabilitation experience at home. However, the comparative efficacy of remote physiotherapy compared with traditional in-person sessions for individuals with Parkinson’s disease (PD) remains uncertain. This study aims to evaluate the effects of TR compared with in-person physiotherapy in individuals with PD, focusing on both motor and non-motor outcomes.

This is a randomised, single-blind clinical trial with a mixed-methods approach. A total of 22 individuals diagnosed with PD will be randomly assigned to one of two groups. The experimental group will receive TR, consisting of remote physiotherapy sessions conducted once a week for 1 hour over a 4-month period. The control group will receive the same interventions in person. Interventions will include global muscle strengthening exercises, balance training, gait and motor coordination exercises, and cognitive training. The primary outcome will be motor function, measured using part III of the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale. Secondary outcomes will include cognition (Montreal Cognitive Assessment), gait (Functional Gait Assessment), mobility (Timed Up and Go Test) and quality of life (Parkinson’s Disease Questionnaire). Data will be analysed using repeated measures analysis of variance to compare outcomes between groups across four assessment points (baseline, midpoint, postintervention and 2 months follow-up). Additionally, a qualitative phase will explore participants’ perceptions and experiences regarding TR and in-person interventions, with assessments carried out 2 months after the completion of the 24-week interventions, through semistructured interviews that will be analysed using Bardin’s Content Analysis technique.

This protocol was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte (approval number: 5.553.701). All participants will provide written informed consent before inclusion. Results will be disseminated through peer-reviewed publications, scientific conferences and communication with participants and healthcare professionals.

RBR-6h5knrj.

To assess awareness of colorectal cancer (CRC) symptoms and risk factors among adults attending Sri Lanka’s largest tertiary care hospital, and to identify sociodemographic predictors of awareness.

Descriptive cross-sectional study.

Outpatient clinics at the National Hospital of Sri Lanka (NHSL), the country’s largest tertiary care centre.

A total of 506 adults (≥18 years) recruited via convenience sampling. Data were collected from May 2022 to May 2023 at the outpatient clinics of the NHSL, the country’s largest tertiary care centre. Eligible participants included clinic attendees as well as accompanying persons of attendees, provided they met inclusion criteria. Individuals with known gastrointestinal conditions or malignancies were excluded.

Primary outcomes: awareness scores of CRC symptoms and risk factors using a culturally adapted Bowel Cancer Awareness Measure questionnaire.

Secondary outcomes: predictors of awareness based on sociodemographic variables.

58.7% (n=297) of participants could not name any CRC symptoms unprompted; blood in stools (n=93, 18.4%) was the most identified symptom unprompted. Prompted awareness improved markedly, with 75.3% (n=381) identifying blood in stools when provided with a list. Similarly, 44.3% (n=224) could not identify any CRC risk factors unprompted; excessive alcohol intake (n=368, 72.7%) and low fibre intake (n=324, 64.0%) were the most commonly recognised risk factors when prompted. The mean symptom awareness score was 5.63 (SD=2.55), corresponding to ‘fair’ awareness, and the mean risk factor awareness score was 5.47 (SD=2.63), also indicating ‘fair’ awareness. Female gender (B=0.669, p=0.008; n=237) and older age (B=0.023, p=0.034) were significantly associated with higher symptom awareness. Awareness was significantly lower among participants with lower education (B = –0.104, p=0.018; n=219) and among the unemployed (B = –0.175, p=0.045; n=152).

Unprompted awareness of CRC symptoms and risk factors was suboptimal in this population, with marked gaps in spontaneous recall. Public health campaigns should prioritise men, younger adults and individuals with lower education to enhance CRC literacy and promote earlier detection.

Sexual and gender-based violence can have long-term impacts on the physical and mental health of survivors, with demonstrated impairments to immune, endocrine and nervous systems, and increased risk of chronic conditions such as cardiovascular disease, depression and post-traumatic stress. Moreover, survivors commonly experience low self-efficacy and lack of perceived control over their lives. Creating space for survivors to feel empowered through a multidimensional approach to health promotion, considering both physical and psychological influences on health, is necessary to reduce chronic disease.

In this type II hybrid effectiveness-implementation cluster randomised controlled trial, we evaluate a novel peer-led intervention that combines expressive writing and trauma-informed boxing, Left Write Hook, against trauma-informed boxing alone—an intervention approach that is currently accessible in the community and has been shown to improve both mental and physical health. 20 clusters of 8–10 adults (n=150) with a self-reported history of child sexual abuse or other gender-based violence will be recruited in Melbourne, Australia, through health services and the community. Clusters will be randomly assigned to complete either 8x weekly group sessions of Left Write Hook (intervention) involving both expressive writing and trauma-informed boxing led by a trained peer facilitator, or 8x weekly group boxing sessions led by a trauma-informed boxing facilitator (control). Implementation will be evaluated against the PRISM Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. The primary effectiveness outcome is change in self-efficacy from preintervention to postintervention (8 weeks). Secondary effectiveness outcomes are changes in symptoms of complex post-traumatic stress disorder, trauma-related cognition and indicators of physical fitness (strength, flexibility, aerobic fitness and balance). Assessment will be completed online or over the phone with a member of the research team at preintervention (0 weeks), postintervention (8 weeks) and at 1 month following completion of the intervention (12 weeks). The primary implementation outcome is the fidelity of the train-the-champion implementation strategy for intervention training and delivery, and the secondary implementation outcome is adoption of the intervention and training delivery.

Ethical approval was received from the Human Research Ethics Committee of The University of Melbourne (2024-28998-60131-11) and the Alfred Hospital Ethics Committee (110810). Results will be disseminated via publication in a peer-reviewed journal, and data will be made available via Open Science Framework at the conclusion of the trial.

ACTRN12624000862549.

Surgical oncology patients often experience doubts and uncertainties in the preoperative and postoperative periods, which can be addressed remotely through telenursing. Expanding telenursing services could contribute to more comprehensive perioperative care. We conducted a scoping review to characterise these telenursing services, identify their outcome indicators and examine the content of the care delivered.

A scoping review was conducted in accordance with the Joanna Briggs Institute (JBI) recommendations.

MEDLINE (PubMed), EMBASE, CINAHL, SCOPUS, Web of Science and Virtual Health Library (VHL), with searches performed up to 5 May 2025.

We included studies that implemented telenursing interventions in the preoperative or postoperative period in adult oncology patients.

Two independent reviewers used a standardised search to select and extract data from the included studies. Study characteristics were presented descriptively using absolute and relative frequencies, and the content of telenursing interventions was organised into a circular thematic matrix.

A total of 37 studies were included, published between 1996 and 2024, conducted in 12 countries and primarily focused on postoperative telenursing via telephone or video calls. Preoperative care focused on psychosocial support and guidance related to surgical preparation. Postoperative topics included surgical wound care; handling of devices such as drains, ostomy bags and catheters; instructions for returning to work and support groups for financial and social assistance. Outcome indicators were primarily related to care, including levels of anxiety, stress, depression and quality of life.

Oncologic surgical telenursing remains primarily focused on postoperative care and the delivery of personalised support. Reporting on the protocols used, frequency and duration of sessions, nurse training and profiles, integration with in-person care workflows and operational cost data could strengthen the knowledge base for perioperative telenursing in oncology.