Self-care plays a pivotal role in the management of heart failure (HF). Health literacy and empowerment are considered the prerequisites of effective self-care. This project aims to improve self-management in people with HF by describing, analysing and enhancing the communication practices of clinicians and patients to support people with HF to increase their health literacy skills and participate in shared decision-making.

A multimethod research design incorporating an interview component, a concurrent mixed-methods component and a pilot intervention study is used. The study is currently being conducted at two Australian hospitals in metropolitan areas (one public and one private). The interview component involves semistructured interviews with healthcare providers and hospital executives and managers at the participating sites to explore perceived barriers and facilitators to HF self-management and understand the institutional context of HF care. The concurrent mixed-methods components include: (a) tracking and audio recording the clinical interactions of patients with HF (n=30) during their hospitalisation and up to 6 months after discharge and semistructured interviews with the patient (and the carer) and the participating clinician after each clinical interaction and (b) collecting longitudinal survey data (n=180, patients) to track patients’ health literacy, empowerment and self-management over 6 months. The pilot feasibility study includes developing a complex intervention for clinicians and patients and evaluating its acceptability and potential in improving health literacy and reducing readmissions, length of stay and costs.

This study was approved by the Australian Capital Territory Health (2023.ETH.00007) and Edith Cowan University (023–04314-SAUNDERS) Human Research Ethics Committees. Informed consent was obtained and will continue to be sought from all participants. Study results will be disseminated in peer-reviewed journals.

Observational data are increasingly used to study and draw causal inferences about the effects of treatments. Target trial emulation (TTE) is a framework for mitigating biases in causal investigations through specification of an observational study, targeting a specific causal research question, based on a real or hypothetical randomised controlled trial. Investigations into the effects of treatment discontinuation are of growing interest and particularly relevant in cystic fibrosis (CF), where treatment burden is high and new transformative therapies are becoming widespread. We aim to use the TTE framework to investigate the effect of discontinuation of inhaled corticosteroids (ICS) on clinical outcomes in people with CF. Our observational emulation will be based on the CF WISE (Withdrawal of Inhaled Steroids Evaluation) trial (PMID:16556691).

Two study designs proposed for investigating treatment effects using observational data are the prevalent new-user design and the sequential trials design. Each design uses different but related methods to address similar causal questions; however, the comparability between them remains uncertain. We will conduct a population-based cohort study using data from the UK CF Registry between January 2016 and June 2018 and apply these designs. We will specify the target trial protocol for each study design. Estimates for the causal effects of discontinuing ICS will be obtained and compared with those from the CF-WISE trial.

This study has received approval from the UK CF Registry Research Committee for both the research and access to data. Ethical approval has also been granted by the LSHTM Ethics Committee. The UK CF Registry has NHS Research Ethics Committee approval (REC reference: 24/EE/0012). The findings from this project will be submitted to peer-reviewed journals and presented at academic conferences.

Care pathways are crucial for patients with mental health disorders and should be designed to support integrated rehabilitation while reducing the burden of these disorders. The contemporary shift toward an outpatient follow-up model of care presents an opportunity to improve mental health care beyond the stagnation in advancements in pharmacological treatments. Various pharmacist-led interventions exist and can serve as levers to address ongoing challenges in mental health care pathways: they could help manage difficult transitions, ensure continuity between inpatient and outpatient care, and reduce high rehospitalisation rates. However, the contexts in which these solutions benefit patients and improve care outcomes remain unclear. Thus, the primary objective of this study will be to identify how pharmaceutical solutions contribute to improving mental health care pathways, what works, for whom and in what context. The secondary objective will be to identify the key outcomes currently used to evaluate the impact of pharmaceutical solutions on care pathways.

A systematic realist review will be conducted, following 5 iterative steps to synthesise heterogeneous evidence: (1) Scope definition with a general review of the literature and experts’ discussions, (2) Initial programme theory development based on the preliminary searches, (3) Systematic review for evidence, to refine and test initial programme theory across PubMed, Embase and Web Of Science, (4) Data extraction, including context-mechanism-outcome configurations, and evidence appraisal and (5) Data analysis, synthesis and refined programme theory construction with the realist logic. This process will involve consensus among expert researchers, incorporating insights from individuals with lived experience.

The final programme theory modelling will result in a new framework for pharmaceutical solutions applied in diverse mental health contexts. The findings of this systematic realist review could serve as a guide for implementing pharmaceutical solutions across healthcare settings, ensuring that interventions are evidence-based, contextually relevant and grounded in real-world needs.

As this realist review will collect previously published data and will not involve human or animal participants, no ethical approval is required. Since this manuscript is a review protocol, no datasets were generated or analysed. All data extraction forms will be made available as part of the publication of the realist review.

Systematic review registration PROSPERO 2025 CRD420251011954.

Dates of the study: September 2025 to September 2026.

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.