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.

Multiple sclerosis (MS) is a chronic neurological condition that affects approximately 150 000 people in the UK and presents a significant healthcare burden, including the high costs of disease-modifying treatments (DMTs). DMTs have substantially reduced the risk of relapse and moderately reduced disability progression. Patients exhibit a wide range of responses to available DMTs. The Predicting Optimal INdividualised Treatment response in MS (POINT-MS) cohort was established to predict the individual treatment response by integrating comprehensive clinical phenotyping with imaging, serum and genetic biomarkers of disease activity and progression. Here, we present the baseline characteristics of the cohort and provide an overview of the study design, laying the groundwork for future analyses.

POINT-MS is a prospective, observational research cohort and biobank of 781 adult participants with a diagnosis of MS who consented to study enrolment on initiation of a DMT at the Queen Square MS Centre (National Hospital of Neurology and Neurosurgery, University College London Hospital NHS Trust, London) between 01/07/2019 and 31/07/2024. All patients were invited for clinical assessments, including the expanded disability status scale (EDSS) score, brief international cognitive assessment for MS and various patient-reported outcome measures (PROMs). They additionally underwent MRI at 3T, optical coherence tomography and blood tests (for genotyping and serum biomarkers quantification), at baseline (i.e., within 3 months from commencing a DMT), and between 6–12 (re-baseline), 18–24, 30–36, 42–48 and 54–60 months after DMT initiation.

748 participants provided baseline data. They were mostly female (68%) and White (75%) participants, with relapsing–remitting MS (94.3%), and with an average age of 40.8 (±10.9) years and a mean disease duration of 7.9 (±7.4) years since symptom onset. Despite low disability (median EDSS 2.0), cognitive impairment was observed in 40% of participants. Most patients (98.4%) had at least one comorbidity. At study entry, 59.2% were treatment naïve, and 83.2% initiated a high-efficacy DMT. Most patients (76.4%) were in either full- or part-time employment. PROMs indicated heterogeneous impairments in physical and mental health, with a greater psychological than physical impact and with low levels of fatigue. When baseline MRI scans were compared with previous scans (available in 668 (89%) patients; mean time since last scan 9±8 months), 26% and 8.5% of patients had at least one new brain or spinal cord lesion at study entry, respectively. Patients showed a median volume of brain lesions of 6.14 cm³, with significant variability among patients (CI 1.1 to 34.1). When brain tissue volumes z-scores were obtained using healthy subjects (N=113, (mean age 42.3 (± 11.8) years, 61.9% female)) from a local MRI database, patients showed a slight reduction in the volumes of the whole grey matter (–0.16 (–0.22 to –0.09)), driven by the deep grey matter (–0.47 (–0.55 to –0.40)), and of the whole white matter (–0.18 (–0.28 to –0.09)), but normal cortical grey matter volumes (0.10 (0.05 to 0.15)). The mean upper cervical spinal cord cross-sectional area (CSA), as measured from volumetric brain scans, was 62.3 (SD 7.5) mm². When CSA z-scores were obtained from the same healthy subjects used for brain measures, patients showed a slight reduction in CSA (–0.15 (–0.24 to –0.10)).

Modelling with both standard statistics and machine learning approaches is currently planned to predict individualised treatment response by integrating all the demographic, socioeconomic, clinical data with imaging, genetic and serum biomarkers. The long-term output of this research is a stratification tool that will guide the selection of DMTs in clinical practice on the basis of the individual prognostic profile. We will complete long-term follow-up data in 4 years (January 2029). The biobank and MRI repository will be used for collaborative research on the mechanisms of disability in MS.

Caesarean birth (CB) under neuraxial anaesthesia (NA) is the most performed inpatient operation in the UK. The incidence of intraoperative pain during caesarean delivery performed under neuraxial anaesthesia is unclear, with limited data that used patient-reported measures to investigate intraoperative pain. The short- and medium-term impacts on patients of this adverse event are unknown.

We will undertake a multicentre, prospective observational cohort study to evaluate the incidence and impact of pain experienced by patients during CB performed under neuraxial anaesthesia. Routine audit data will be collected for all patients undergoing caesarean delivery for any indication during a 1 week window at participating hospitals within the UK and Queensland, Australia. The dataset will include patient, anaesthetic, obstetric and neonatal risk factors for intraoperative pain. Local investigators will then seek informed consent from patients either before or within 24 hours of delivery to record patient experience and patient-reported outcomes at 24 hours and 6 weeks postdelivery. Local investigators at participating hospitals will also complete a survey evaluating compliance with evidence-based structural standards at their sites. The patient characteristics, structures, processes and outcomes will be described. Inferential techniques will be used to evaluate the relationship between risk factors and postoperative outcomes.

This study received ethical approval from the Leicester Health Research Authority and Care Research Wales, REC reference 24/EM/0084) on 24 May 24. The study received ethical approval from the Human Research Ethics Committee of Metro North Health in Australia on 25 March 2024 (REC Ref HREC/2024/MNHA/103767). The results of the study will be reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology statement. The results will be disseminated via conference presentations, peer-reviewed academic journals and reports prepared for patients, the public and policy makers.

ISRCTN15269213.

Bloodstream infection (BSI) due to multidrug-resistant Gram-negative bacilli is a serious global health problem that has a profound impact on severely immunosuppressed neutropenic haematological patients. Prompt institution of appropriate antimicrobial therapy is crucial for improving outcomes in these patients, and in an era of multidrug resistance, antimicrobial stewardship programmes are mandatory. Blood cultures, the current gold standard for the diagnosis of BSI, present two main drawbacks: the prolonged time to results and their low sensitivity, especially if the patient has received antimicrobial treatment before blood extraction. The aim of this study is to determine whether a molecular technique, the BioFire FilmArray Blood Culture Identification 2 (BCID2) panel, achieves higher sensitivity and specificity than conventional blood cultures for the microbiological diagnosis of BSI in haematological patients with febrile neutropenia.

This multicentre, prospective, observational study will be conducted at three reference university hospitals in Spain. The population will comprise haematological patients scheduled to undergo diagnostic blood cultures as standard care for the microbiological diagnosis of the febrile neutropenia episode. The BioFire FilmArray panel will be performed in patients with positive blood cultures at the time of blood culture positivity and in patients with negative blood cultures at 48 hours of incubation. The primary endpoint will be the sensitivity and specificity of the BioFire FilmArray BCID2 panel compared with conventional blood cultures. The secondary endpoints will be this same comparison in the subgroup of patients with recent (

The study protocol has been approved by the Clinical Research Ethics Committee at Bellvitge Hospital (reference number ICPS029/22) and the Institutional Review Boards at each participating site. All patients’ personal data will be processed, disclosed and transferred in accordance with Organic Law 3/2018 of 5 December 2018 and Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016. All data will be collected, stored and processed anonymously. Results will be reported at conferences and in peer-reviewed publications regardless of whether the hypothesis is demonstrated. Any formal presentation or publication of data collected from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the International Committee of Medical Journal Editors.

The aim of this study is to assess the impact of the BCID2 panel on the diagnostic yield of BSI in haematological patients with febrile neutropenia. Unlike previous studies, which focused on patients with documented BSI, our research will include all patients with febrile neutropenia.

NCT06787326.