After resuscitation from out of hospital cardiac arrest (OHCA), mechanical ventilation (MV) and respiratory management are fundamental to support patients in the intensive care unit (ICU) and to minimise secondary brain injury. Best practices for MV and association with clinical outcomes in patients with OHCA remain unclear.

This protocol describes a pre-planned respiratory-focused series of sub-analyses within the Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, an ongoing interventional study evaluating 6-month mortality after randomisation in patients admitted to ICUs following OHCA. The primary aim is to describe real-world ventilator settings and gas-exchange targets during the first 72 hours after ICU admission in patients receiving invasive mechanical ventilation after OHCA. Secondary aims include to estimate the incidence of respiratory complications during ICU stay (eg, ventilator-associated pneumonia, acute respiratory distress syndrome, barotrauma); and to explore the association between early ventilator settings/gas-exchange parameters and 6-month outcomes (mortality and neurological status). Exploratory aim is to characterise weaning and extubation practices, including timing and failure rates.

Eligible patients will include adult STEPCARE participants receiving invasive MV after return of spontaneous circulation with available respiratory data recorded within the STEPCARE database.

Data collected in the STEPCARE trial that will be analysed include patients’ prehospital characteristics; clinical examination at hospital admission and at ICU admission; ventilator settings and arterial blood gases recorded at predefined time points during ICU stay. In particular: MV setting (mode, tidal volume, positive end-expiratory pressure, fraction of inspired oxygen, tidal volume, mechanical power, plateau/driving pressures), gas-exchange values (arterial partial pressure of oxygen and carbon dioxide, pH, arterial saturation of oxygen), timing of measurements and the occurrence/timing of respiratory complications and weaning outcomes.

The STEPCARE study has been approved by the regional ethics committee at Lund University (Dnr 2022-02425-01, Approved IRB on 2022-06-18) and by all ethics boards in the participating countries. No additional ethical approval is required for this predefined secondary analysis, as no further data collection or interventions will be performed. Findings will be disseminated through publication in peer-reviewed journals and, where appropriate, conference abstracts and presentations. Patients and the public were not involved.

NCT05564754.

Referrals to speech and language pathology are infrequent for people with Parkinson’s disease (PD), despite speech and communication being often affected and greatly impacting their quality of life. This study investigated the knowledge, self-competence and challenges faced by speech and language pathologists (SLPs) in Malaysia when managing PD cases.

Participants self-administered an online-survey in a cross-sectional study design. The survey consisted of 14 questions on current practices of SLPs with their patients with PD, self-perceived competence when assessing and managing PD and perceived barriers for catering to patients with PD. Inferential statistics were run on self-perceived competence across domains and their relationship with demographic/current practice factors. Descriptive statistics were used to analyse perceived barriers.

The survey was administered in English through Google Forms.

54 Malaysian SLPs with at least one active case of PD in their caseload were invited via email and WhatsApp Messenger. These contacts were obtained from the Speech-Language Therapists Association of Malaysia (SPEAK), and snowball sampling was encouraged to recruit additional SLPs through other social networks.

To quantify Malaysian SLPs’ self-perceived competence levels (assessed on 5-point Likert scales) in assessing and managing five key domains in patients with PD: speech, language, oro-motor skills, cognition and swallowing; and to identify the frequency and types of barriers encountered in clinical practice with patients with PD through structured multiple-choice questions. Secondary outcomes included quantifying current service delivery patterns (frequency of PD referrals, stage at referral, caseload size), multidisciplinary consultation patterns and confidence levels in managing rehabilitation risks associated with PD, all measured through structured survey items with categorical or ordinal response options.

Most participants had 1–5 patients with PD in their active caseload, referred at a middle or advanced stage of the disease. The majority of participants felt competent in assessing and managing motor speech and language in patients with PD. Conversely, most of them did not feel competent in assessing and managing cognition in these patients, regardless of demographic factors or current practices. This difference was significant. Most participants also reported facing barriers such as health conditions or comorbidities, family expectations on the therapy outcome and the unavailability of a multidisciplinary approach.

The study reveals that SLPs working in Malaysia feel competent in working with motor speech and language in individuals with PD. However, it highlights a need for additional training to address cognitive assessment and management as a crucial tool to boost functional communication in people with PD. The study also reveals a need for promoting a multidisciplinary approach.

Cytoreductive surgery (CRS) with heated intraperitoneal chemotherapy (HIPEC) is a treatment for peritonitis carcinomatosa. These procedures often involve significant blood and fluid loss, leading to hyperdynamic circulation and vasodilation, necessitating intraoperative fluids and vasoconstrictors such as catecholamines. Excessive fluid administration to counteract vasodilation can cause intraoperative fluid overload, which is linked to increased postoperative complications. Vasopressin has emerged as a potential alternative to catecholamines, restoring vascular tone via non-adrenergic pathways and supporting perfusion pressure, potentially reducing the need for compensatory fluids solely administered to compensate for vasodilation. We hypothesise that compared with norepinephrine, vasopressin reduces cumulative intraoperative fluid administration during CRS-HIPEC within a goal-directed fluid therapy (GDFT) protocol, ultimately leading to a lowering of postoperative complications.

HiPress is a two-centre, two-arm randomised clinical trial with blinding of both patients and outcome assessors. A total of 70 adult patients undergoing CRS-HIPEC will be included. Patients will be randomised to receive either continuous low-dose argipressin or continuous low-dose norepinephrine. Both groups will receive standardised GDFT during the procedure. The primary endpoint is cumulative intraoperative fluid administration (mL). Secondary endpoints include direct fluid-related outcomes (eg, cumulative intraoperative fluid (ml/kg/hour), postoperative fluid balance until day five and ultrasound-assessed pulmonary oedema and venous congestion) and indirect fluid-associated outcomes (eg, quality of recovery, surgical and abdominal complications, acute kidney injury (AKI), pulmonary complications, length of ICU and hospital stay and 30-day mortality).

The study is enrolling patients since February 2025. The trial is approved by the Medical Research Ethics Committee (hereinafter: MREC) NedMec, The Netherlands (Ref: D-25-500202). Results of the trial will be published in an international peer-reviewed journal and announced at national and international scientific meetings.

Clinical Trials Information System (CTIS): European Union clinical trials register (EUCT) number: 2024–5 13 598-33-00

A clinical prediction model (IMPROVE) for ipsilateral ischaemic stroke risk in symptomatic patients with carotid disease was recently developed with good performance. We aim to evaluate the model-based cost-effectiveness of IMPROVE-based triage versus triage in care-as-usual (CAU) for optimal medical treatment (OMT) alone or carotid endarterectomy plus OMT.

A dataset of 678 patients with carotid disease and a recent ipsilateral ischaemic stroke, transient ischaemic attack or amaurosis fugax from four cohort studies informed a decision-analytic model. Stratification of patients for carotid endarterectomy was based on ≥50% carotid stenosis (CAU arm) or a range of 3-year ipsilateral ischaemic stroke risk thresholds (IMPROVE arm). The threshold resulting in the lowest number of ipsilateral strokes and perioperative strokes and deaths was selected as the optimal threshold. Patients with

IMPROVE-based triage reduced ipsilateral ischaemic strokes and perioperative strokes and deaths by 34.5% (CAU: 4.3%, IMPROVE: 2.8%) over 3 years. Revascularisations decreased by 20% with IMPROVE, while Quality-Adjusted Life Years slightly increased. Procedural stroke occurred in 1.8% of patients in CAU versus 1.4% of patients for IMPROVE. Societal costs decreased on average by 1441/patient for IMPROVE versus CAU for a 3-year time horizon (lifetime cost reduction: 6101/patient). Subgroup analyses identified IMPROVE as the superior strategy for 50–69% and 70–99% stenosis (3-year and lifetime horizon) and

In this modelling analysis, triage of symptomatic patients with carotid disease with the IMPROVE model can lead to the prevention of one-third of ipsilateral ischaemic strokes and perioperative strokes and deaths, while also reducing societal costs. These findings should be validated in a clinical trial.

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a significant procedural adverse event (AE), occurring in 5–15% of cases and leading to substantial morbidity and mortality. Aggressive prolonged intravenous (IV) fluid regimens have demonstrated efficacy in reducing PEP in clinical trials. However, these regimens typically involve continuous infusion of IV fluids over 8–24 hours following ERCP, making them impractical for outpatient settings. Data on shorter hydration protocols are lacking. The STRIPE study aims to address this gap by evaluating short-term peri-procedural IV fluid regimens as a practical alternative for mitigating PEP.

This proof-of-concept, parallel-arm, randomised controlled trial will evaluate the impact of various short-term IV fluid regimens on post-ERCP serum amylase levels, a surrogate marker for PEP. Participants undergoing ERCP will be randomised into five groups, receiving 500 mL, 1000 mL, 1500 mL, 2000 mL or 2500 mL of IV Ringer’s lactate during the peri-procedural period. Patients, endoscopists and outcome assessors will be blinded to treatment allocation during the peri-procedural period. The primary outcome is the serum amylase level 24 hours post-ERCP. Secondary outcomes include PEP, 30-day AEs and unplanned healthcare encounters including those related to volume overload or cardiovascular AEs, duration of hospitalisation (for inpatients), death within 30 days and other relevant laboratory markers at 24 hours. A total of 505 participants (101 in each arm) will be enrolled to ensure adequate power after accounting for attrition and/or sample loss.

This trial was registered on clinicaltrials.gov on 7 February 2024. The study was approved by the University of Calgary Conjoint Health Research Ethics Board (REB23-0625). On study completion, data will be made available on reasonable request to the corresponding author after completion of the study. Study dissemination and knowledge translation is planned via presentations at scholarly meetings, publications in peer-reviewed journals and, ideally, via adoption of results into clinical practice guidelines.

NCT06260878.

Each year over 130 000 patients in the UK are discharged from an intensive care unit (ICU), with many experiencing poor outcomes such as in-hospital mortality, emergency ICU readmission and/or significant morbidity. Despite current national guidance and the availability of follow-up services, post-ICU care remains variable. Critical Care Outreach Teams (CCOTs) are key in supporting this patient group, yet practice differs considerably. Recovery pathways have been successfully employed in other patient populations and are a potential option to standardise post-ICU care. Understanding how care is currently delivered by CCOT throughout the UK is essential to inform future development of an evidence-based recovery pathway for this patient group. Our primary aim is to understand how post-ICU follow-up care is delivered within the wider remit of CCOT workloads.

This is a pragmatic multicentre qualitative study of post-ICU follow-up care. The study will be split into two sub-studies: semi-structured interviews and ethnographic observations. Semi-structured interviews will be conducted with three groups of individuals: multi-professional staff members involved in the care of patients discharged from ICU to the wards, patients discharged from ICU to the wards and their family members. Direct participant observations alongside ad hoc informal discussions will be undertaken with members of the CCOT at participating sites focusing on their workflow to generate an understanding of the CCOT role and how post-ICU support fits within this. An overarching thematic analysis approach will be taken to analyse data from both sub-studies to clearly identify the barriers and facilitators to providing post-ICU support within the CCOT role.

Ethical approval has been obtained through the London—Chelsea Research Ethics Committee (25/PR/0773). We aim to disseminate the findings to local teams, at regional and international conferences, in peer-reviewed journals and through social media.

ISRCTN14138257.

Chronic back and neck pain are commonly treated with opioid analgesics, gabapentinoids and benzodiazepines, despite their high-risk profile and potential limited efficacy. Deprescribing interventions (aimed at medicine reduction or cessation) have shown some effectiveness in reducing the use of these medications, but similar approaches tailored to individuals with complex chronic back and/or neck pain are lacking and urgently needed. This trial will evaluate the effect of the safer analgesia (SAGE) intervention (training of general practitioners (GPs) in deprescribing and support to deprescribe) on cessation and/or reduction of the target high-risk medicine (a benzodiazepine, gabapentinoid or opioid) for people with chronic back and/or neck pain.

SAGE is a pragmatic cluster randomised trial that will be conducted with at least 30 general practices in Australia randomly assigned in a 1:1 ratio to the SAGE intervention or no intervention (usual care control group). The SAGE intervention is a GP-facing intervention comprising (i) training for GPs in deprescribing and access to deprescribing resources and (ii) deprescribing support—to assist the deprescribing process for their patients, GPs can conduct a long GP consultation (20–40-min duration), refer to trained physiotherapists for the provision of psychologically informed physiotherapy sessions and provide alternate pain management options including heat wrap and diclofenac gel. A total of 320 adult patient-participants experiencing chronic back and/or neck pain (≥ 3 months duration) prescribed a target high-risk medicine (benzodiazepine, gabapentinoid or opioid) persistently for this pain will be recruited via participating general practices. The primary outcome is cessation of dispensation of the trial participant’s high-risk medicine (a benzodiazepine, gabapentinoid or opioid) prescribed by their trial GP. The primary time-point for the primary outcome will be 1-year post-enrolment with an observation window of the preceding 4 weeks. Secondary outcomes include self-reported outcomes such as pain, quality of life and adverse events. Analyses will follow an intention-to-treat approach with a nested economic evaluation and per-protocol analysis planned separately.

The study received approval from the University of Sydney Human Research Ethics Committee (2024/HE001706). The results will be disseminated via publication in a peer-reviewed scientific journal, presentation at conferences and media.

ANZCTR: ACTRN12625000953437.

Of 1.2 million children and young adolescents (

Decide TB is a pragmatic, hybrid effectiveness-implementation type 2 cluster-randomised trial with a stepped wedge design. The comprehensive TDA-based approach (intervention) will be implemented under programmatic conditions in four districts in each country (each comprising one DH and six PHCs), randomly selected to switch sequentially from the standard of care to the intervention. Evaluations will assess epidemiological, clinical, economic, social sciences, implementation and health policy endpoints. Aggregated and individual data from children with presumptive TB will be extracted from facility registers and individual data will be collected using an electronic medical record (EMR), both data sources will be entered in national Demographic Health Information System 2 databases. Questionnaires and individual/group interviews (among healthcare workers (HCWs), parents/caregivers and key informants), supervision and mentoring reports and quantitative cost tools will be used.

Ethics approval was obtained from national ethics committees in Mozambique (Instituto Nacional de Saúde review board and National Committee for Bioethics in Health) and Zambia (University of Zambia ethical review board and National Health Research Authority); this includes a waiver for analysing data collected by NTPs (no identifiable information reported, intervention with minimal risk) without individual consent from children’s parents/caregivers. Informed consent will be obtained from HCWs, parents/caregivers and key informants. Results will be openly shared with the scientific community, WHO and national and international stakeholders for translation into policy and practice. Procedures for requesting further use of Decide TB data will be publicly available.

NCT06593080; PACTR202407866544155.

Early open fracture management aims to minimise the risk of complications. For the most severe open fracture wounds, multiple irrigation and debridement surgeries are required to overcome severe wound contamination, to reassess the evolving tissue injury or to temporise and plan further surgery. When multiple irrigation and debridement surgeries are needed, uncertainty remains about how the open fracture wound should be managed to best minimise complications. The primary aim of this trial is to compare the antibiotic cement bead pouch vs negative pressure wound therapy in the management of patients with severe open tibia fracture wounds.

BvV is a multicentre, pragmatic, parallel arm randomised controlled trial that aims to enrol 312 adult patients admitted to a participating centre with a severe open tibia fracture requiring multiple irrigation and debridement surgeries. Participants will be randomly allocated on a 1:1 basis to either antibiotic cement bead pouch or negative pressure wound therapy. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomisation. Using the win ratio approach, we will hierarchically assess the composite outcome in the following order: (i) all-cause mortality, (ii) injury-related amputation of the lower extremity, (iii) unplanned reoperation to manage wound complications, an infection or promote fracture healing and (iv) clinical fracture healing assessed using the Functional IndeX for Trauma (FIX-IT) instrument.

The BvV trial has been approved by a central institutional review board (IRB) (Advarra) for clinical sites in the USA, the ethics board at the coordinating centre at McMaster University (Hamilton Integrated Research Ethics Board), and participating sites not using the central institutional IRB (Fraser Health Research Ethics Board, The University of British Columbia Clinical Research Ethics Board, Newfoundland and Labrador Health Research Ethics Board, University of Manitoba Biomedical Research Ethics Board). Additional clinical sites who are in the start-up phase, as well as any new selected clinical sites, will obtain local approvals prior to initiating trial activities. This will include a clinical site in the UK who is in the process of obtaining the necessary approvals. Recruitment began in November 2023. Both interventions are frequently used to manage severe open fracture wounds, ensuring that the trial results can be easily transitioned into clinical practice. The results of this trial will be disseminated to national and international partners through peer-reviewed publications, academic conferences and stakeholder engagement activities.

NCT05615844.

Trichomonas vaginalis is estimated to be the most common non-viral sexually transmitted infection (STI) worldwide with 156 million new cases each year. In 2021, the United States Centres for Disease Control and Prevention (CDC) updated their STI Treatment Guidelines to recommend multi-dose oral metronidazole (MTZ) for all T. vaginalis-infected women. Although multi-dose oral MTZ 500 mg twice daily was found to be superior to single-dose 2 g oral MTZ in multiple trials in women, multi-dose oral MTZ still had unacceptably high rates of breakthrough infection (9%–11%) at test-of-cure. With approximately 156 million cases of T. vaginalis worldwide per year, over 17 million persons per year are estimated to be insufficiently treated with multi-dose oral MTZ. Moreover, past trials only included women, and single-dose 2 g oral MTZ remains the recommended treatment for men. Thus, there is a critical need to further refine T. vaginalis treatment in women and men. A single dose of 2 g of oral secnidazole (SEC), a next generation 5-nitroimidazole with a longer half-life than oral MTZ and improved tolerability, may be a good option. This study will examine the effectiveness of multi-dose oral MTZ versus single-dose oral SEC in both men and women infected with T. vaginalis.

This is a multi-centred open-label effectiveness trial comparing oral multi-dose MTZ (500 mg twice daily for 7 days) to 2 g of single-dose oral SEC. This trial aims to enrol 1200 T. vaginalis-infected women and men aged 18 years and older at four clinical sites: the University of Alabama at Birmingham (UAB) Sexual Health Clinic and the UAB Gynaecology Clinics in Birmingham, AL, LSU-CrescentCare Sexual Health Centre (LSUHSC-NO) in New Orleans, LA, and HealthCare Clinical Data, Inc. in Miami, FL. Those who are pregnant/lactating, have been treated with a 5-nitroimidazole within the last 28 days, used intra-vaginal boric acid or any other intra-vaginal treatment for T. vaginalis within the last 14 days, have a history of a type 1 hypersensitivity reaction to 5-nitroimidazoles, are taking phenytoin and/or warfarin, use any medications which may alter the metabolism of oral MTZ, or have previously been enrolled will be excluded from the study. Participants will be randomised in a 1:1 fashion to either multi-dose oral MTZ or single-dose oral SEC. A test-of-cure (TOC) visit will be performed 4 weeks after completion of treatment (window 1 week before and 2 weeks after scheduled TOC visit).

This protocol is approved through a single Institutional Review Board (IRB) mechanism by the Tulane Human Research Protection Programme (Protocol # 2024–101 SPHTM). External relying sites are the UAB IRB (including both the UAB Sexual Health Research Clinic and Gynaecology Clinics; Protocol ID IRB-300012617), the LSUHSC-NO IRB (LSU-CrescentCare Sexual Health Centre; Protocol ID 6979) and the Advarra IRB (Healthcare Clinical Data Inc; Protocol ID Pro00085531). This study is also approved for referral purposes only by the Research Review Committee at the Jefferson County Department of Health (JCDH) Sexual Health Clinic in Birmingham, AL (JCDH Research Number 2024–03). Study findings will be presented in scientific conferences and peer-reviewed journals, shared with treatment advisory boards, as well as disseminated to providers and patients in communities of interest. The study Data Safety and Monitoring Board (DSMB) will meet twice a year to review patient safety data and study progress and provide recommendations on the study’s continuation or modification.

NCT06261840.

Although important learnings come from traditionally designed large prospective asthma cohorts, highly restrictive inclusion and exclusion criteria limit generalisability to clinical practice. Moreover, small sample sizes for important disease subtypes, narrow scope of clinical data collection and limited biomarker assessments reduce the power of some studies to detect important and diverse longitudinal disease courses. The Real-world and Genomic data-based Asthma Insights through Network Analysis (REGAIN) study takes a novel approach to asthma cohort development by employing a pragmatic definition of asthma and simplified study procedures for biospecimen and data collection. REGAIN will produce a large scale, real-world, longitudinal clinical and molecular description of asthma powered to characterise and compare clinically relevant asthma subtypes. This design will provide insights on distinct longitudinal trajectories of disease, predictors of response to therapies and likelihood of clinical remission, all of which should help guide asthma management.

REGAIN is a clinical observational retrospective and prospective cohort study designed to determine large scale, real-world longitudinal clinical and molecular descriptions of asthma according to types of treatment, level of asthma control and inflammatory biology based on clinical biomarkers. Key questions include predictors of change in asthma control as well as timing and durability of clinical remission on biological therapy. To complement these clinical insights, REGAIN will produce one of the largest multiscale data sets in asthma that will include demographic and clinical features, inflammatory biomarkers, responses to therapy with inhaled steroids and other inhaled controllers with or without asthma biologics, and serial airway epithelium and peripheral blood transcriptomics and proteomics. REGAIN targets enrolment of 780 participants with asthma fitting one of five prespecified asthma subtypes with the aim of better characterising under-studied groups and allowing comparative analyses to elucidate important differential therapeutic responses and clinical trajectories. We target enrolment of 400 healthy controls to provide a healthy state molecular description of the tissues sampled in REGAIN participants with asthma. Participants with asthma are followed prospectively for 18 months with assessment of longitudinal clinical status including prospective clinical data collection, integration of electronic medical record data and serial biospecimen collection at 6 and 18 months. Participants with asthma starting treatment with asthma biologics undergo additional clinical assessment and biospecimen sampling at 3 months to track early clinical and molecular response to therapy. Healthy participants without asthma are evaluated cross-sectionally on enrolment without longitudinal follow-up in order to compare molecular profiles for airway epithelium and blood. An optional study component for participants with asthma employs a mobile phone application, digital inhaler monitors and home digital peak flow measurements and contributes data on real-time medication use, serial lung function and geolocated environmental data relevant to asthma.

The REGAIN protocol and all amendments were approved by The Icahn School of Medicine at Mount Sinai Program for Protection of Human Subjects (PPHS19-0358), and all participants provided written informed consent. Enrolment began in November 2019 and was completed in February 2024. Results will be presented at local, national and international meetings, and results will be submitted to peer-reviewed journals for consideration for publication.

NCT06623435.

The objective of this study was to investigate the utility of the days alive and out of hospital (DAOH) metric within a cohort of patients undergoing burr-hole drainage of a chronic subdural haematoma (CSDH). We evaluate the validity of the DAOH metric in a national CSDH cohort and examine how the DAOH metric compares to its constituent outcomes (mortality and hospital bed days) at an organisational level.

Retrospective cohort study using Hospital Episode Statistics data linked to the national death registry to identify patients who underwent burr-hole drainage of CSDH in English National Health Service neurosurgical units between 1 April 2013 and 31 March 2020. Construct validity was assessed by measuring the patterns of DAOH across categories of known perioperative risk factors. Variation between units in the risk-adjusted values for DAOH, postoperative mortality and days in hospital was explored using funnel plots. Linear regression and logistic regression were used to derive the risk-adjusted rates.

Overall, 16 450 patients who underwent at least one burr-hole drainage of CSDH were identified during the time period. The median 30-day DAOH was 16 (IQR, 0–24); the median for the 90-day DAOH was 74 (42–84), and was better at measuring the complete stay associated with the index admission. Worse 90-day DAOH values were associated with older age, increasing comorbidities and greater frailty. Risk-adjusted 90-day DAOH values for neurosurgical units varied more markedly than for its constituent outcomes.

The 90-day DAOH looks to be a valid outcome metric for patients undergoing burr-hole drainage for CSDH that is feasible to derive using national hospital data. Future work should explore how to estimate a minimally important clinical difference for DAOH and evaluate its utility as an outcome measure.

Treatment with bevacizumab achieves both tumour stabilisation or regression and preservation or improvement of hearing. However, the efficacy of bevacizumab varies between patients and within patients. Side effects due to bevacizumab treatment are also common. It would be of value to predict therapeutic response prior to initiating therapy to prevent unnecessary exposure in patients unlikely to benefit.

We aim to recruit 25 patients with NF2-related schwannomatosis (NF2) with bilateral vestibular schwannomas. Patients will receive an intravenous injection of 37 MBq [⁸⁹Zr]bevacizumab followed by positron emission tomography (PET)/CT imaging 4 days later. After clinical evaluation at baseline, patients undergo bevacizumab treatment and are followed up at 3 and 6 months. The primary objective is to examine associations between pretreatment [⁸⁹Zr]bevacizumab uptake on PET/CT and changes in multiple hearing outcomes and radiological characteristics of the target tumour following treatment. Secondary outcome measures include vestibular functioning, patient reported outcome measures, cranial nerve functionality, peripheral neurology, non-target schwannoma response and renal function. Given the explorative nature of the study, associations between PET-derived metrics and clinical and radiological outcomes will be examined without formal hypothesis testing, using generalised estimating equations to account for within-patient correlation. Pairwise associations will be summarised in an association matrix with multiplicity addressed using an all-resolutions inference approach, and findings will be considered hypothesis generating.

This study was submitted via the Clinical Trials Information System reviewed and approved by the Medical Research Ethics Committee Leiden–The Hague–Delft Delft. The study findings will be disseminated through publication in peer-reviewed scientific journals and by presentation at national and international conferences.

The trial is registered at ClinicalTrials.gov Protocol Registration and Results System under the registration ID: NCT05685836.

Strong primary healthcare enhances resource efficiency and resilience. Type 2 diabetes poses a growing global health challenge, with Argentina’s healthcare system struggling to detect and manage the disease effectively. Many patients bypass primary healthcare for secondary facilities, undermining continuity of care and increasing costs. Following a diagnostic process in collaboration with policymakers, we propose evaluating a redesigned primary care model consisting of codesigned evidence-based implementation strategies to improve type 2 diabetes management in Mendoza, Argentina.

This is an efficient, parallel-arm cluster randomised controlled Hybrid Type II trial with 12 clusters (administrative areas with 2–3 health facilities) allocated 1:1 to control (usual care) or intervention. In phase I, we will codesign, pilot and refine an implementation strategy package. In phase II, we will conduct the trial: 9-month baseline data collection, 15-month intervention and 6-month sustainability period. We will enrol a cohort of 396 patients with type 2 diabetes at primary healthcare centres and follow them for 12 months during the intervention and 6 months sustainment using routine clinical records and patient surveys. In phase III, we will conduct analysis, report and disseminate findings. The primary outcome will be a composite outcome including glycaemic control (glycated haemoglobin (HbA1c)

All study activities will comply with national and international ethics guidelines, presenting minimal risk to participants. The protocol was submitted and approved by the local independent ethics committee at the Mendoza Ministry of Health (Consejo Provincial de Evaluación ética en investigación en Salud-Provincial Health Research Ethics Review Board, Reference number: 149/2024). Facility-level permission will be obtained for participation and sharing of deidentified data. Written informed consent will be required from study participants, who will receive information on the study’s purpose, procedures, risks and benefits. Dissemination activities and outputs will include writing and submitting manuscripts for publication; writing policy briefs to support strategy implementation in other regions or countries; and tailoring outputs for patients, clinicians and researchers. We anticipate that improvements in disease management and patient experience will have clinical and economic benefits related to reduced usage of secondary-level and tertiary-level facilities, lower cost per visit and a reduced number of clinical events related to diabetes.

ISRCTN63277390.

Virtual Wards (VWs) facilitate hospital-level monitoring, diagnostics and treatment within patients’ homes, while the hospital team retains responsibility for care. International research indicates that VWs decrease hospital length of stay without increasing readmissions; however, the feasibility and key operational determinants within Dutch care remain uncertain. This protocol outlines the VW for Early Discharge in Patients Receiving Inpatient Care (VIP Care) study.

The VIP Care study is a single-centre prospective feasibility cohort study conducted at Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands. The study encompasses seven predefined subcohorts with n=51 eligible patients per subcohort: (1) bacterial, fungal or parasitic infections; (2) viral respiratory infections; (3) dehydration; (4) decompensated heart failure; (5) high-dose corticosteroid treatment; (6) post-transsphenoidal pituitary surgery follow-up and (7) severe inflammatory skin disease with or without bacterial or viral superinfection. Adults who require hospital-level monitoring and/or therapy may qualify for early discharge to the VW.

The VW integrates scheduled, patient-performed measurements using (European Conformity) CE-marked devices with structured symptom assessment submitted via a patient application, and data review in an electronic health record-integrated clinician cockpit. Submissions are evaluated by VW tele-nurses using prespecified Early Warning Score based thresholds and an escalation protocol. Patients receive a daily physician telephone review. Diagnostics and treatments are administered at home to hospital standards through established home-care services.

The primary outcome (feasibility) is adherence to transfer, defined as the proportion of eligible inpatients who provide written informed consent and are subsequently successfully transferred to the VW. The prespecified feasibility threshold is 30%. Secondary outcomes include reach (eligibility, invitation and consent rates among admitted patients), operational performance during the VW episode (alert frequency and handling, contact volumes and actions), length of stay on the ward and in the VW, emergency department reassessments and 30-day readmissions. Qualitative interviews will be conducted to identify implementation determinants.

The study received approval from the Erasmus MC Medical Ethics Committee (MEC-2024–0060; amendment MEC-2024–0060 A0001). Incremental risk is considered minimal. Written informed consent is obtained. Findings will be disseminated through peer-reviewed publications, conference presentations and an accessible lay summary.

ClinicalTrials.gov NCT06936891; CCMO NL85516.078.24. Recruitment began in May 2025 and is ongoing.

The standard treatment for high-grade squamous intraepithelial lesions is excisional involving the uterine cervix, while surveillance is an acceptable approach for low-grade squamous intraepithelial lesions. There is controversy about excisional treatment on pregnancy outcomes. The objective of this study was to determine pregnancy outcomes in women living with and without HIV who underwent excisional treatment for high-grade cervical intraepithelial lesions.

This retrospective cohort study compared the pregnancy outcomes of women with and without HIV who were or were not treated for cervical intraepithelial lesions. A cohort of 488 women with and without HIV infection who did or did not receive excisional treatment for cervical intraepithelial lesions between 2009 and 2022 was enrolled. Adverse pregnancy outcomes (preterm delivery and pregnancy loss) in women with and without HIV, untreated or treated for cervical dysplasia, were recorded and analysed. The significance of the obtained results was judged at the 5% level.

The study was conducted at all Academic Model Providing Access to Healthcare-Kenya satellite sites, which offer cervical cancer screening and treatment for cervical dysplasia in western Kenya. The Moi Teaching and Referral Hospital was also included.

A cohort of 488 women aged between 20 years and 49 years, with and without HIV, diagnosed and treated for high-grade cervical intraepithelial neoplasia, and those followed up for low-grade cervical intraepithelial neoplasia between 2009 and 2022, were included.

The study was interested in adverse pregnancy outcomes, particularly pregnancy loss and preterm delivery following cervical excision treatment for high-grade cervical intraepithelial lesions.

After adjustment for confounding factors, excisional treatment involving the uterine cervix—particularly cold knife conisation—was associated with higher odds of adverse pregnancy outcomes (OR 13.1; 95% CI 1.1 to 137.1; p=0.032). A prior history of adverse pregnancy outcomes was also strongly associated with subsequent adverse outcomes after treatment (OR 37.7; 95% CI 13.8 to 102.7; p

Adverse pregnancy outcomes after excisional treatment of the uterine cervix for high-grade squamous intraepithelial lesions are multifactorial and were associated with cold knife conisation and prior adverse pregnancy outcomes, while maternal HIV infection was not independently associated with adverse outcomes.

Malaria remains a major public health challenge in India, with transmission dynamics varying widely across ecological, epidemiological, sociobehavioural and health system contexts. Achieving the national malaria elimination target by 2030 requires integrated, context-specific evidence to design effective interventions. This study aims to generate a comprehensive understanding of malaria transmission and factors surrounding it across diverse eco-epidemiological settings in India by assessing malaria burden, identifying determinants of transmission, evaluating health system performance and equity, characterising vector bionomics and insecticide resistance, and examining the influence of environmental drivers.

This longitudinal, multicentric study will be conducted in collaboration with the national programme in 12 districts spanning 10 states in India, covering a population of around 25 000 individuals representing varied ecological contexts (urban, periurban, rural, forest-foothill and coastal) and malaria endemicity levels. In each district, two clusters (villages) with a population of 1000 individuals will be included. A baseline mass survey will estimate malaria prevalence using bivalent rapid diagnostic tests (RDTs) and blood smear microscopy, with low-density parasitaemia detected by PCR in a subset of RDT-negative samples. Participants will be followed for 1 year, with monthly screening of symptomatic individuals using RDT and microscopy, and testing a subset of asymptomatic individuals to detect subclinical infections. Sociobehavioural data will be collected through structured interviews and household observations, with purposive inclusion of vulnerable groups, pregnant women, migrants, elderly persons, individuals with disabilities and tribal populations to assess equity dimensions through mixed-methods approaches. Health system performance will be evaluated through key informant interviews with programme officials, health workers, patients, private practitioners and traditional healers. Entomological surveillance will document vector species composition, density, infection rates and assessment of susceptibility status and intensity of insecticide resistance to commonly used public health insecticides. Environmental variables, including temperature, rainfall and humidity, will be linked with entomological and epidemiological data to explore spatiotemporal relationships.

The protocol was approved by the Institute Human Ethics Committee of ICMR-Vector Control Research Centre (IHEC 03-0125/N/F). All standard ethical practices will be adhered to. The findings will be shared with stakeholders and published in reputed open-access journals.

Nutrition counselling is recommended after pancreatic cancer surgery given the complex nutritional problems patients experience. In practice, access and delivery of nutrition counselling after pancreatic surgery varies across settings. To address this gap, our study team developed the Support Through Remote Observation and Nutrition Guidance (STRONG) programme, an implementation strategy that addresses common barriers to nutrition care delivery in oncology.

The STRONG programme includes a standardised protocol to specify the timing and amount of nutrition counselling that should be delivered and patient-mediated implementation strategies including collection of patient-reported information, an educational brochure summarising common nutrition problems and recommended dietary strategies after pancreatic surgery and a question prompt list for the patient-dietitian encounter. A pilot randomised controlled trial will be conducted to assess the feasibility and acceptability of the STRONG programme compared with usual care in pancreatic cancer surgery patients after hospital discharge (n = 80). The trial is designed to be pragmatic and integrated into existing workflows and clinic teams. The primary goal will be to compare feasibility and acceptability outcomes against pre-planned benchmarks. Data will be collected from patients and caregivers and healthcare providers who assist with STRONG implementation. Secondary goals include collecting preliminary data on effectiveness and implementation outcomes that will support a future definitive hybrid implementation-effectiveness trial.

This study was approved by the Moffitt Cancer Center Institutional Review Board of Record, Advarra (Pro00071143). Participants will be required to provide written consent prior to enrolment. Study findings will be disseminated through plain language summaries, conference abstracts and peer-reviewed publications.

ClinicalTrials.gov NCT06001268. Registered on 21 August 2023, prior to participant enrolment.

Viral hepatitis B (HBV) and C (HCV) infections remain major public health threats in Ghana, with prevalence rates significantly higher in prison populations than in the general population. Despite this, incarcerated individuals are frequently excluded from national testing and treatment programmes. Overcrowding, poor sanitation and limited access to healthcare create a high transmission risk. There is an urgent need for targeted, evidence-based interventions to address this health inequity and support Ghana’s progress towards viral hepatitis elimination.

This protocol describes a study designed to evaluate the effectiveness of a multicomponent targeted educational intervention in increasing knowledge, intention to test, testing uptake and treatment initiation for HBV and HCV among adult prison inmates in the Greater Accra and Eastern Regions of Ghana.

A cluster randomised controlled trial (RCT) with a 1:1 parallel design will be conducted in eight prisons stratified by gender (six male, two female) with 208 inmates per arm. The intervention group will receive the Prison Education for Prevention of Hepatitis Intervention, comprising an education programme (posters, infographics, film screenings, peer-led discussions and structured health education) alongside HBV and HCV testing, treatment and care linkage. The control group will receive standard health education and basic printed materials. Testing intentions, uptake, prevalence and treatment outcomes will be measured. Cost-effectiveness analysis will inform sustainability and scale-up. The primary endpoint is uptake of hepatitis B and C testing. Secondary outcomes include changes in hepatitis knowledge and testing intentions, prevalence of hepatitis B and C, treatment uptake among diagnosed inmates, linkage to hepatitis care services and cost-effectiveness of the intervention.

Data will be analysed, accounting for prison clustering, using mixed-effects models and regression methods. Outcomes include testing uptake, knowledge, intentions, prevalence, treatment initiation and sustained virologic response, adjusted for key covariates. Baseline characteristics and intervention reach will be summarised descriptively. Analyses will follow intention-to-treat and Consolidated Standards of Reporting Trials guidelines. Cost-effectiveness will estimate Incremental Cost Effectiveness Ratio (ICERs) per inmate tested, infection detected and treatment initiated.

The RCT was approved by the College of Health Sciences ethics and protocol review committee (no. CHS-E/M.1-P 4.7/2025–2026). Results will be presented at relevant national and international meetings and conferences and will be published in international peer-reviewed journals. Furthermore, we plan to communicate the results to relevant stakeholders in the Ghanaian Prisons and Healthcare systems.

PACTR202512558588684.