Older adults transitioning to nursing homes face challenges in adapting to a new environment and imposed lifestyle changes. This study aimed to identify factors associated with poor nursing home adjustment and to assess their impact on 1-year mortality.

This study is a secondary analysis of the KArukera Study of Ageing in ‘Établissement d'Hébergement pour Personnes Agées Dépendantes’ (EHPAD) (KASEHPAD) cohort, a prospective observational study conducted over 1 year in six nursing homes in the French Caribbean.

159 older adults (aged 60 years or older) living in nursing homes who were able to complete the self-administered adaptation scale.

Nursing home adjustment was assessed at baseline using the adaptation scale for older adults to their residence (EAPAR). Bivariate analysis was used to assess associations between adjustment status and sociodemographic or clinical characteristics at baseline. Poisson regressions were used to assess the relationship between 1-year mortality and adjustment status.

A total of 159 older adults (mean age: 79.6 years; male/female ratio: 84/75) were included. The mean length of stay was 4.1 years. Among older adults, 78 (49.1%) were classified as poorly adapted. Age, gender, education level, dependency, cognition and comorbidities were not significantly associated with poor adjustment. In contrast, depressive symptoms, lower social support, lower health-related quality of life, lower subjective quality of life, malnutrition and sleep disturbances were associated with poor adjustment. After 12 months, 14 deaths (17.9%) occurred in the poor adjustment group, compared with 4 (4.9%) in the no major adjustment difficulties group (adjusted relative risk for age, gender and baseline activities of daily living score=4.64 (95% CI 1.53 to 17.5; p=0011).

In a sample of older adults with moderate cognitive impairment, poor adjustment to nursing home was associated with depressive symptomatology and increased 1-year mortality. The issue of adjustment in nursing homes represents an emerging research area that warrants further investigation through dedicated interventional studies.

NCT04587466.

Postoperative pulmonary complications (PPCs) are common after cardiac surgery and are associated with significant morbidity and mortality. Lung-protective ventilation strategies have been proposed to reduce PPCs, but the optimal level of positive end-expiratory pressure (PEEP) and the use of alveolar recruitment manoeuvres (RMs) remain controversial.

In this investigator-initiated, multicentre, open, randomised, parallel-group, superiority clinical trial, elective cardiac surgery patients at risk of PPCs will be assigned to one of two intraoperative ventilation strategies: (1) an open-lung ventilation strategy with protective ventilation, moderate PEEP and RMs or (2) a standard protective ventilation with low PEEP and no RM. The primary outcome will be a composite of prolonged (>24 hour) postoperative mechanical ventilation, reintubation for any cause or hospital-acquired pneumonia within 7 days of surgery, or death within 28 days of surgery. Data will be analysed on an intention-to-treat basis.

The VACARM (impact of intraoperatiVe moderAte positive end-expiratory pressure with reCruitment mAnoeuvres versus low positive end-expiRatory pressure on major postoperative pulMonary complications and death after on-pump cardiac surgery in high-risk patients) trial has been approved by an independent ethics committee for all study centres. Recruitment began in July 2021. Results will be published in international peer-reviewed medical journals.

ClinicalTrials.gov NCT04408495.

Suicide is a leading cause of preventable death worldwide. Evidence supports the impact of providing active contact for individuals who have attempted suicide. The current systematic review and meta-analyses aim to investigate the effects of suicide prevention strategies implemented through remote and synchronous technology-based interventions.

Systematic review, narrative synthesis and meta-analysis.

Electronic databases (PubMed, PsycINFO, Scopus and Web of Science) and grey literature sources (ClinicalTrials.gov and Google Scholar) were searched until December 2024.

Eligible articles assessed suicide prevention interventions for participants over 12 years with prior suicidal behaviour. Eligible study designs included randomised controlled trials and non-randomised clinical trials published in English or Spanish.

Screening, selection process, data extraction and risk of bias assessment were performed independently by two reviewers. Data on suicide-related factors and adherence to treatment were extracted. Meta-analyses were conducted to determine effect sizes (Hedges’ g) for suicidal ideation, risk ratios (RR) for suicide attempts and Peto odds ratios (OR) for suicide. Heterogeneity was assessed using the Cochrane’s Q test, tau² statistic and I² value. Publication bias was investigated employing funnel plots and Egger’s test.

A total of 28 studies, comprising 10 015 participants in the intervention group and 10 726 in the comparison group, were included in the systematic review and meta-analyses. Synchronous remote-based interventions were effective in preventing repeated suicide attempts at 1 month (RR 0.73, 95% CI 0.62 to 0.85, I²=0.0%, Q=0.70, tau²=0.00), 6 months (RR 0.56, 95% CI 0.34 to 0.95, I²=85.4%, Q=54.92, tau²=0.36) and 12 months (RR 0.68, 95% CI 0.49 to 0.96, I²=87.6%, Q=72.63, tau²=0.27). Additionally, these interventions were associated with a reduction in suicide-related deaths at 18 months (Peto OR 0.18, 95% CI 0.08 to 0.44, I²=0.0%, Q=0.03, tau²=0.00). Effects on suicidal ideation were not statistically significant at any time point (Hedges’ g –0.07 to –0.28, I²=0.0 to 69.3%, Q=1.16 to 7.38, tau²=0.00 to 0.14).

Synchronous remote-based interventions demonstrate a potential benefit in preventing suicide attempts and deaths by suicide and may serve as an adjunct to usual treatment; however, the effect on suicidal ideation appears limited. The observed heterogeneity warrants caution when interpreting these findings. Future research should prioritise methodological enhancements to improve the quality and consistency of evidence, as well as investigate the mediating processes underlying their effectiveness in reducing suicidal behaviour.

CRD42021275044.

The combination with corticosteroids as immunomodulators has been the subject of debate in different infectious syndromes. The main objective of this study is to evaluate the efficacy (the percentage of patients hospitalised with influenza with a status of 3 or higher according to the Hospital Recovery Scale (HRS) on day 7 after the start of treatment) and safety of dexamethasone.

Investigator-initiated multicentre, blinded, randomised placebo-controlled trial with two parallel treatment arms. The study population will consist of adult patients (over 18 years of age) hospitalised with severe influenza. One arm will receive one capsule of 6 mg of dexamethasone for 7 days, and the other arm will receive one capsule of placebo for 7 days of antibiotic treatment for 7 days or longer. Both groups will receive oseltamivir (75 mg/12 hours orally) for 5 days, extendable to 10 days depending on the investigator decision. Randomisation will occur in equal proportion (1:1). Patients with bronchial hyper-responsiveness that requires systemic corticosteroids for more than 24 hours, preinclusion treatment with corticosteroids for more than 24 hours at a dose equal to or higher than 1 mg/kg methylprednisolone (0.2 mg/kg dexamethasone or 1.25 mg/kg prednisone), inability to administer oral oseltamivir, patients with severe comorbidity with a life expectancy of

The study is approved by the Institutional Review Board of Alicante Health Department—Dr. Balmis General University Hospital (LOC-100061146). The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal

NCT06528444.

To increase the sustainability of healthcare, clinical trials must assess the environmental impact of interventions alongside clinical outcomes. This should be guided by Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) extensions, which will be developed by The Implementing Climate and Environmental Outcomes in Trials Group. The objective of the scoping review is to describe the existing methods for reporting and measuring environmental outcomes in randomised trials. The results will be used to inform the future development of the SPIRIT and CONSORT extensions on environmental outcomes (SPIRIT-ICE and CONSORT-ICE).

This protocol outlines the methodology for a scoping review, which will be conducted in two distinct sections: (1) identifying any existing guidelines, reviews or methodological studies describing environmental impacts of interventions and (2) identifying how environmental outcomes are reported in randomised trial protocols and trial results. A search specialist will search major medical databases, reference lists of trial publications and clinical trial registries to identify relevant publications. Data from the included studies will be extracted independently by two review authors. Based on the results, a preliminary list of items for the SPIRIT and CONSORT extensions will be developed.

This study does not include any human participants, and ethics approval is not required according to the Declaration of Helsinki. The findings from the scoping review will be published in international peer-reviewed journals, and the findings will be used to inform the design of a Delphi survey of relevant stakeholders.

Registered with Open Science 28 of February 2025.

The WHO has declared climate change the defining public health challenge of the 21st century. Incorporating climate and environmental outcomes in randomised trials is essential for enhancing healthcare treatments’ sustainability and safeguarding global health. To implement such outcomes, it is necessary to establish a framework for unbiased and transparent planning and reporting. We aim to develop extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2025) and Consolidated Standards of Reporting Trials (CONSORT 2025) statements by introducing guidelines for reporting climate and environmental outcomes.

This is a protocol for SPIRIT and CONSORT extensions on reporting climate and environmental outcomes in randomised trials termed SPIRIT-Implementing Climate and Environmental (ICE) and CONSORT-ICE. The development of the extensions will consist of five phases: phase 1—project launch, phase 2—review of the literature, phase 3—Delphi survey, phase 4—consensus meeting and phase 5—dissemination and implementation. The phases are expected to overlap. The SPIRIT-ICE and CONSORT-ICE extensions will be developed in parallel. The extensions will guide researchers on how and what to report when assessing climate and environmental outcomes.

The protocol was submitted to the Danish Research Ethics Committees, Denmark in June 2025. Ethics approval is expected in September 2025. The SPIRIT and CONSORT extensions will be published in international peer-reviewed journals.

Patients in intensive care units (ICUs) frequently require mechanical ventilation, with approximately half needing invasive ventilation through an orotracheal tube. For these patients, gastric tube (GT) insertion is routinely performed to administer nutrition and medications or to drain gastric contents. The insertion route (oral or nasal) may affect the incidence of ventilator-associated pneumonia (VAP), a significant ICU care complication. This study aims to compare the impact of oral versus nasal GT insertion on the incidence of VAP in intubated ICU patients.

The SONG trial (NCT 05915663) is a multicentre, open-label, two-period, two-intervention, cluster randomised crossover superiority trial. 16 French ICUs will participate. ICUs will be randomised to periods of nasogastric or orogastric tube placement. The trial includes a practice standardisation period, followed by two 12-month inclusion periods separated by a monitoring and washout period. The primary endpoint is the incidence rate of VAP at day 28, confirmed by three independent physicians. Secondary endpoints include the ease of GT insertion, measured by the number of attempts.

This study received approval from a central ethical review board on 12 April 2024 (CPP Sud-est VI, registration number 23.00943.000175). Patients are included after informed consent or, when not possible, from next of kin. If none are available, the investigator will proceed with emergency inclusion, following French law. When consent is initially obtained from the next of kin or through emergency inclusion, the investigator will seek consent from the patient as soon as possible. Data will be anonymised and patient confidentiality maintained. Results will be published in peer-reviewed journals and presented at scientific meetings.

NCT05915663.

Preterm infants are at risk of developmental impairment, especially those born before 33 weeks gestational age. Many studies have shown a positive impact of early interventions on medical outcomes during hospitalisation, long-term cognitive development and parental anxiety. Infant Behavioral Assessment and Intervention Program (IBAIP) has shown positive effects on cognitive development but also on motor impairment in a Dutch cohort. We aim to confirm these results in a multicentric, cluster randomised controlled trial in a French setting.

Eight French neonatal intensive care units (NICUs) will be randomised before study initiation to intervention or control group. We aim to include 240 infants born between 25 weeks and 33 weeks gestational age. IBAIP intervention comprises monthly home visits with a trained professional from hospital discharge until 6 months corrected age. Both groups receive standard care according to local organisation. The primary endpoint is composite cognitive score at 2 years corrected age using Bayley Scale of Infant Development Fourth Edition (BSID IV). Secondary endpoints include BSID IV subscores, Ages and Stages Questionnaire scores and parental stress. Analysis is in intention to treat. Univariate and multivariate analysis will be performed on primary and secondary endpoints.

Informed consent from one or both parents will be necessary for all patients. Study results will be published in peer-reviewed scientific journals. If our hypothesis is confirmed, IBAIP could be implemented on a nationwide scale. The study was registered with clinicaltrials.gov (ID: 29BRC17.0219).

NCT04685356.

In the intensive care unit (ICU), brain-injured patients are frequently exposed to mechanical ventilation to protect the brain and preserve physiology. After intracranial pressure control and sedation withdrawal, this population is prone to residual disorder of consciousness and altered neurological control of respiratory drive, cough and airway protection. Consequently, extubation failure is more frequent than in general ICU patients, and there is no clear evidence-based clinical trigger for extubation. Different risk factors for extubation failure were described in observational trials, and clinical scores were constructed to detect patients at higher risk of extubation failure. Nevertheless, none of these scores were prospectively tested as interventional tools to prevent extubation failure. The Brain-Injured Patients Extubation Readiness (BIPER) study is an ongoing multicentre stepped-wedge cluster-randomised controlled trial aiming to test one of these scores as an intervention protocol to decrease extubation failure in neurocritical care patients with residual disorder of consciousness.

Trial design: Stepped-wedge cluster-randomised controlled trial with five groups of three to six clusters (20 ICUs). Groups of clusters are randomised to five possible sequences of nine periods with crossing from a control condition period (usual care for extubation) to an intervention condition period (BIPER-guided extubation protocol), separated by a 3-month transition period.

Participants: Participants are clinically stable brain-injured patients (18–75 years old), requiring more than 48 hours of invasive mechanical ventilation with residual disorder of consciousness after sedation withdrawal, and who achieved a spontaneous breathing trial.

Interventions: The control condition consists of extubation based on usual care and local practice. The intervention condition consists of extubation triggered by a clinical score evaluating deglutition, gag reflex, cough and visual tracking (Coma Recovery Scale-Revised Visual Scale).

Objective: To determine whether adoption of an extubation protocol based on a clinical score can lessen extubation failure compared with usual care in brain-injured patients with residual disorder of consciousness.

Outcome: The primary outcome measure is extubation failure, defined within 5 days following extubation. The key secondary outcome measure is time to effective extubation.

Randomisation: Clusters are allocated to sequence of treatments using random blocks randomisation. The constitution of groups of clusters was stratified according to planned recruitment of each centre.

Blinding: Investigators and outcome assessors are not blinded to condition allocation.

Number of participants: 660 patients (220 in the control condition and 440 in the intervention condition).

The BIPER trial was approved by an independent ethics committee. The study began on 9 February 2020, and 571 participants are now included. Results will be published in an international peer-reviewed medical journal. 

NCT04080440.