The ‘time-limited trial’ for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient’s response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.

We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials’ conceptual formulation and their heterogeneous, real-world use.

This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.

NCT06042621.

To explore why there is variation in implementation of multifactorial falls prevention practices that are recommended to reduce falls risks for older patients in hospital.

Mixed method, realist evaluation.

Three older persons and three orthopaedic wards in acute hospitals in England.

Healthcare professionals, including nurses, therapists and doctors (n=40), and patients aged 65 and over, and carers (n=31).

We examined mechanisms hypothesised to underpin the implementation of multifactorial falls risk assessment and multidomain, personalised prevention plans.

We developed an explanation detailing that how contextual factors supported or constrained implementation of recommended falls prevention practices.

Nurses led delivery of falls risk assessment and prevention planning using their organisation’s electronic health records (EHR) to guide and document these practices. Implementation of recommended practices was influenced by (1) organisational EHR systems that differed in falls risk assessment items they included, (2) competing priorities on nurse time that could reduce falls risk assessment to a tick box exercise, encourage ‘blanket’ rather than tailored interventions and that constrained nurse time with patients to personalise prevention plans and (3) established but not recommended falls prevention practices, such as risk screening, that focused multidisciplinary communication on patients screened as at high risk of falls and that emphasised nursing, rather than Multidisciplinary Team (MDT), responsibility for preventing falls through constant patient supervision.

To promote consistent delivery of multifactorial falls prevention practices, and to help ease the nursing burden, organisations should consider how electronic systems and established ward-based practices can be reconfigured to support greater multidisciplinary staff and patient and carer involvement in modification of individual falls risks.

Inside CKD aims to assess the burden of chronic kidney disease (CKD) and the cost-effectiveness of screening programmes in Belgium.

Microsimulation-based modelling.

Data derived from national statistics and key literature from Belgium.

Virtual populations of ≥10 million individuals, representative of Belgian populations of interest, were generated based on published data and cycled through the Inside CKD model. Baseline input data included age, estimated glomerular filtration rate (eGFR), urine albumin-creatinine ratio (UACR) and CKD status.

Outcomes included the clinical and economic burden of CKD during 2022–2027 and the cost-effectiveness of two different CKD screening programmes (one UACR measurement and two eGFR measurements or only two eGFR measurements, followed by renin-angiotensin-aldosterone system inhibitor treatment in newly diagnosed eligible patients). The economic burden estimation included patients diagnosed with CKD stages 3–5; the screening cost-effectiveness estimation included patients aged ≥45 years with no CKD diagnosis and high-risk subgroups (with cardiovascular disease, hypertension, type 2 diabetes or aged ≥65 years).

Between 2022 and 2027, CKD prevalence is estimated to remain stable and substantial at approximately 1.66 million, with 69.9% undiagnosed. The total healthcare cost of patients diagnosed with CKD is expected to remain stable at approximately 2.15 billion per year. The one UACR, two eGFR measurement screening programme was cost-effective in all populations, with an incremental cost-effectiveness ratio of 3623 per quality-adjusted life year (QALY) gained in those aged ≥45 years, well below the estimated willingness-to-pay threshold of 43 839 per QALY gained.

Without changes to current practice, the disease burden of CKD in Belgium is predicted to remain substantial over the next few years. This highlights the need for timely diagnosis of CKD and demonstrates that, in line with guideline recommendations, implementing a CKD screening programme involving UACR and eGFR measurements followed by treatment would be cost-effective.

Infection prevention and control (IPC) interventions are multifactorial and are used to prevent healthcare-associated infections in healthcare facilities. However, patient views and enabling patient and public involvement (PPI) in their development has been minimal.

This systematic review aims to identify peer-reviewed publications reporting patient satisfaction outcomes in the context of IPC interventions, to document the methods used to assess patient satisfaction and to conduct a meta-analysis on reported satisfaction outcomes.

Systematic review and meta-analysis following the Joanna Briggs Institute (JBI) methodology and the PRISMA statement, with oversight from a steering group including PPI partners. Studies in peer-reviewed journals were included based on eligibility criteria.

MEDLINE, Scopus, Web of Science, EMBASE, Cochrane Library, CINAHL and PsycINFO were searched in June 2024.

Included studies investigated satisfaction among hospitalised patients in acute care settings following IPC measures, including isolation, cohorting, screening, hand hygiene, antimicrobial stewardship, patient flagging, education, personal protective equipment use, visiting restrictions and treatment delays

Titles and abstracts were screened independently by two reviewers; disagreements were resolved by a third. Study quality was assessed using the JBI manual for evidence synthesis. A meta-analysis was conducted where four or more studies used comparable designs and methods within the same areas of IPC, with heterogeneity evaluated using Cochran’s Q statistic and I² and pooled estimates calculated with 95% CIs using the Wilson (score) method.

Twenty-nine studies were identified. Among IPC measures, isolation precautions were the most commonly reported intervention (11 studies, 38%). The Likert scale was the predominant assessment method (13 studies, 45%). Patient satisfaction with IPC interventions ranged from 58.3% to 97.2%. Meta-analysis of four studies using the Hospital Consumer Assessment of Healthcare Providers and Systems survey showed substantial heterogeneity (I², 55%, p=0.08) and a pooled patient satisfaction level of 69% (95% CI 63.6% to 74.4%) for isolation precautions.

Sixty-nine percent of isolated patients reported satisfaction with their care. Patient satisfaction with IPC interventions varies widely, highlighting limitations in current measurement approaches. Strengthening PPI in the design and evaluation of satisfaction measures is essential to capture meaningful data and improvements in IPC programmes.

IS 2024 CRD42024558385.

Transoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction.

This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/–) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model.

The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals.

NCT06965738.

To determine whether a biopsychosocial model of suicidality, specifically sleep, nutrition, physical exercise, mindfulness, social connectedness, lower socioeconomic status (SES) and sex are uniquely associated with increased suicidal ideation, longitudinally over adolescence.

Longitudinal, prospective cohort study.

A structured self-report questionnaire was collected as part of the Longitudinal Adolescent Brain Study at the University of the Sunshine Coast’s Thompson Institute (Queensland, Australia) from July 2018 to January 2024.

159 Australian adolescents (n=91 female; 68 male) aged 12 to 17 years.

Self-reported suicidal ideation was measured longitudinally. Data were also collected on self-reported lifestyle factors (sleep, nutrition, physical exercise, mindfulness and social connectedness), psychological distress, SES and sex. All measures were collected at 4-monthly intervals for each participant for up to 5 years (maximum of 15 time points).

Significant relationships were identified between increased suicidal ideation and poor sleep (OR 2.6, 95% CI 1.4 to 4.6, p=0.002), socioeconomic disadvantage (SES quintile 1: OR 6.3, 95% CI, 1.8 to 21.8, p=0.004; SES quintile 2: OR 8.7, 95% CI 1.4 to 56.2, p=0.022), psychological distress (OR 5.7, 95% CI 2.1 to 15.6, p≤0.001) and eating habits (β –0.08, 95% CI –0.2 to –0.0).

Poor sleep, socioeconomic disadvantage, psychological distress and eating habits were all found to be significantly associated with increased adolescent suicidal ideation over time. These biopsychosocial factors should be considered in targeted interventions and policies for reducing adolescent suicidality. Further research should employ multilevel modelling to examine factor interactions and rigorously evaluate interventions targeting lifestyle factors and socioeconomic inequalities through randomised controlled trials and quasi-experimental designs.

China has continued to improve tuberculosis (TB) control in the past decade; however, the sudden outbreak of COVID-19 hindered this progress. As a province with a large population and frequent international exchanges, Guangdong has been seriously affected by COVID-19. This study aimed to understand the effect of COVID-19 on TB detection in Guangdong based on the autoregressive integrated moving average (ARIMA) model.

Time-series study.

Guangdong, China.

We used the ARIMA model to quantify the effect of COVID-19 by comparing reported cases during the COVID-19 pandemic with predicted cases under a counterfactual scenario of no COVID-19 pandemic. After model evaluation, we chose ARIMA (0,1,2)(0,1,1)₁₂ as the prediction model. We also highlighted that there were three emergency response periods in which the responses and public responses to COVID-19 varied.

During the pandemic period, the average annual TB notification rate was 57.95/100 000, which decreased by 27.97% compared with the pre-pandemic period. Although it decreased by 6.17% on average annually in the pre-pandemic period, it decreased by 14.92% in 2020 as compared with 2019, but only decreased by 0.34% in 2021 as compared with 2020. The results of the ARIMA model showed that the number of reported cases in 2020 decreased by 6.62% compared with that of the predicted cases, but this decreased by 0.42% only in 2021. The most seriously affected period was the second-level emergency response period in 2020, when the relative difference between reported and predicted cases reached the peak (–16.43%). The least affected period was the third-level emergency response period of 2021, the reported cases recovered and exceeded the predicted cases, with a gap of 0.77%.

TB detection in Guangdong had generally declined during the COVID-19 pandemic, which might be related to the movement restrictions, diverted resources and patients’ concerns. This decline would lead to the delay or even interruption of diagnosis and treatment, which would cause the regression of TB control. To improve TB detection, it is important for stakeholders to take consorted effort during public health emergencies.

Functional foods have demonstrated potential in preventing gastrointestinal and musculoskeletal (osteo-related) disorders; however, evidence from cross-sectional studies in adults remains limited. This study aimed to examine the relationship between the frequency of functional food consumption and the prevalence of gastrointestinal and osteo-related conditions among adults in Bangladesh.

Cross-sectional study.

A face-to-face interview was conducted in Southern Bangladesh.

A total of 959 adults participated. Socio-demographic characteristics, lifestyle factors, health status and patterns of functional food consumption were collected using a structured questionnaire.

The prevalence of gastrointestinal and musculoskeletal (osteo-related) diseases, as well as their associations with the frequency of functional food consumption, were assessed using binary logistic regression.

Gastrointestinal and musculoskeletal (osteo-related) diseases were reported by 55.4% and 44.1% of participants, respectively. Multivariate logistic regression showed that several functional foods were associated with lower odds of gastrointestinal conditions, including regular seed intake (OR=0.35, p=0.034), weekly fibre-rich foods (OR=0.48, p=0.021), weekly probiotics (OR=0.26, p=0.012), monthly probiotics (OR=0.33, p

The consumption of functional foods, particularly seeds, probiotics, fibre-rich foods, nuts, tea/coffee and natural products were associated with a lower risk of gastrointestinal and musculoskeletal diseases in adults. These findings provide robust evidence to inform future prospective studies and support public health strategies in Bangladesh aimed at promoting the consumption of functional foods to prevent diet-related health conditions.

To characterise patient and medication-related patterns observed in drug-related pressure ulcers (DRPUs) and provide descriptive findings that may support future consensus-building.

Multicentre retrospective observational study.

20 hospitals across Japan participated in the study with hospital pharmacists specialised in PU care.

A total of 1113 hospitalised patients with existing PUs were included and classified into three groups (definite, probable and no-possibility of DRPUs) based on predefined criteria.

The primary outcome was the description of medication-related characteristics observed in each DRPU classification group, including polypharmacy, initiation of new medications and dose adjustments. Secondary outcomes included differences in ulcer characteristics and functional status across DRPU categories.

The definite group (n=128, 11.5%) showed a significantly higher prevalence of polypharmacy (83.6% vs 71.1% in the no-possibility group, p

Medication-related characteristics such as polypharmacy, initiation of new medications, dose modifications and use of antipsychotics were more frequently observed in the definite DRPU group. These descriptive findings may help characterise the clinical patterns of DRPUs and may inform future hypothesis generation.

To analyse the impact of selected neonatal care interventions on regional care capacity.

Design

Discrete event simulation modelling based on clinical data.

Neonatal care in the southwest of the Netherlands, consisting of one tertiary-level neonatal intensive care unit (NICU), four hospitals with high-care neonatal (HCN) wards and six with medium-care neonatal (MCN) wards.

44 461 neonates admitted to at least one hospital within the specified region or admitted outside of the region but with a residential address inside the region between 2016 and 2021.

The impact of three interventions was simulated: (1) home-based phototherapy for hyperbilirubinaemia, (2) oral antibiotic switch for culture-negative early onset infection and (3) changing tertiary-level NICU admission guidelines.

Regional neonatal capacity defined as: (1) occupancy per ward level, (2) required operational beds per ward level to provide care to all inside region patients at maximum 85% occupancy, (3) proportion rejected, defined as outside region transfers due to no capacity to provide local care and (4) the weekly rejections in relation to occupancy to provide a combined analysis.

In the current situation, with many operational beds closed due to nurse shortages, occupancy was extremely high at the NICU and HCNs (respectively 91.7% (95% CI 91.4 to 92.0) and 98.1% (95% CI 98.0 to 98.2)). The number of required beds exceeded available beds, resulting in >20% rejections for both NICU and HCN patients. Although the three interventions individually demonstrated effect on capacity, clinical impact was marginal. In combination, NICU occupancy was reduced below the 85% government recommendation at the cost of an increased burden for HCNs, highlighting the need for redistribution to MCNs.

Our model confirmed the severity of current neonatal capacity strain and demonstrated the potential impact of three interventions on regional capacity. The model showed to be a low-cost and easy-to-use method for regional capacity impact assessment and could provide the basis for making informed decisions for other interventions and future scenarios, supporting data-driven neonatal capacity planning and policy development.

Delays in cancer diagnosis for patients with non-specific symptoms (NSSs) lead to poorer outcomes. Rapid Diagnostic Clinics (RDCs) expedite care, but most NSS patients do not have cancer, highlighting the need for better risk stratification. This study aimed to develop biomarker-based clinical prediction scores to differentiate high-risk and low-risk NSS patients, enabling more targeted diagnostics.

Retrospective and prospective cohort study.

Secondary care RDC in London.

Adult patients attending an RDC between December 2016 and September 2023 were included. External validation used data from another RDC.

The primary outcome was a cancer diagnosis. Biomarker-based risk scores were developed using Latent Class Analysis (LCA) and Least Absolute Shrinkage and Selection Operator (LASSO). Model performance was assessed using logistic regression, receiver operating characteristic curves (AUROC) and decision curve analysis.

Among 5821 RDC patients, LCA identified high white cell count, low haemoglobin, low albumin, high serum lambda light chain, high neutrophil-to-lymphocyte ratio, high serum kappa light chain (SKLC), high erythrocyte sedimentation rate (ESR), high C-reactive protein (CRP) and high neutrophils as cancer risk markers. LASSO selected high platelets, ESR, CRP, SKLC, alkaline phosphatase and lactate dehydrogenase. Each one-point increase in score predicted higher odds of cancer (LCA: AOR 1.19, 95% CI 1.16 to 1.23; LASSO: AOR 1.29, 95% CI 1.25 to 1.34). Scores ≥2 predicted significantly higher cancer odds (LCA: AOR 3.79, 95% CI 2.91 to 4.95; LASSO: AOR 3.44, 95% CI 2.66 to 4.44). Discrimination was good (AUROC: LCA 0.74; LASSO 0.73). External validation in 573 patients confirmed predicted increases in cancer risk per one-point LASSO score rise (AOR 1.28, 95% CI 1.15 to 1.42), with a borderline increase for LCA (AOR 1.16, 95% CI 1.06 to 1.27).

Biomarker-based scores effectively identified NSS patients at higher cancer risk. LCA captured a broader biomarker range, offering higher sensitivity, while LASSO achieved higher specificity with fewer markers. These scores may also help detect severe benign conditions, improving RDC triage. Further validation is needed before broader clinical implementation.

The Research Domain Criteria (RDoC) approach initiated by the National Institute of Mental Health provides a comprehensive framework for guiding research on mental illness and health. Since retrospective studies have indicated associations between RDoC characteristics and clinically relevant as well as care-relevant outcomes, there is a need for prospective, theory-driven investigations that systematically link a priori defined assessments of RDoC constructs to clinically and care-relevant outcomes in a transdiagnostic psychiatric sample.

This prospective observational study assesses six domains—Positive Valence Systems, Negative Valence Systems, Cognitive Systems, Social Processes, Arousal and Regulatory Systems and Sensorimotor Systems—employing a comprehensive set of self-report and additional paradigms to assess cognitive functioning developed a priori in alignment with the RDoC framework while also assessing clinically and care-relevant variables (eg, length of hospital stay). A total of 300 adult participants will be recruited among in- and outpatients of two psychiatric hospitals in Germany (patient group) as well as from the general population (healthy control group). Including healthy individuals will allow for the investigation of continuous variations in psychological functioning rather than categorical distinctions between health and disease. Data collection includes self-reports, clinician ratings, file review and behavioural assessments. Electroencephalography is recorded in a subgroup of participants. A confirmatory factor analysis will be conducted to reproduce the factor structure and regression models will be used to investigate associations between RDoC domains and clinically relevant as well as care-related variables.

Ethics approval was obtained from the local ethics committee of the Brandenburg Medical School—Theodor Fontane (E-01-20220822). Results will be disseminated through peer-reviewed journals and academic conferences.

Prescribing high-dose antipsychotics is typically reserved for individuals with treatment-resistant severe mental illnesses, such as schizophrenia, bipolar disorder and psychotic depression. It carries an increased risk of adverse drug effects, necessitating regular monitoring. Non-mental health specialist clinicians may not always be aware when the maximum recommended dose of antipsychotics is exceeded, leading to unintentional high-dose prescribing without recognising the need for additional monitoring or understanding the associated risks. Therefore, providing clinical decision support (CDS) tools to support clinicians and improve the appropriate prescribing of antipsychotics is important. The aim of this study is to understand current prescribing practices and assess the impact of high-dose antipsychotic prescribing on clinical outcomes among hospitalised patients. The findings from this study will shape a future project focused on developing an integrated computerised CDS tool.

This retrospective cohort study will examine antipsychotic prescribing among hospitalised patients using Hospital Electronic Prescribing and Medicines Administration data in Scotland from 2019 to 2023, in linkage with hospital records, Scottish Morbidity Records and primary care prescribing (Prescribing Information System). Patients will be grouped into those prescribed high-dose (exposed), defined as exceeding the 100% maximum recommended British National Formulary dose and normal-dose (unexposed) antipsychotics, followed from their first ever antipsychotic prescription date (index date) until the end of the study, study outcomes or death, whichever happens first. We will quantify high-dose antipsychotic prescribing, profile patient characteristics and use machine learning techniques to assess associations of high-dose antipsychotic prescribing with clinical outcomes, including harms and benefits, but will not attempt to establish causality.

The Health and Social Care Public Benefit and Privacy Policy Panel (HSC-PBPP) has granted ethical approval (ref. 2024-0239) following a Data Protection Impact Assessment, with data securely held and accessed in the National Safe Haven. The results will be published in international peer-reviewed journals and will be shared with clinicians.

Poor medication adherence is associated with poor clinical outcomes, an increase in hospitalisations and increased mortality. This is a multicentre randomised study that evaluates the effectiveness of using a manual pill organiser (MPO) and a custom-developed pill reminder app (PRA) on medication adherence, morbidity, as well as health economic outcomes among Indian elderly individuals taking multiple medications.

The primary objective of this study is to evaluate the impact of MPO and PRA alone or in combination in improving medication adherence among elderly individuals on multiple medications. The secondary objectives include the impact of interventions on the morbidity profile and health-related quality of life. The study also plans to assess the cost-effectiveness and cost-utility of improving medication adherence.

This is a community-based, open-label, factorial-design randomised controlled trial to be conducted across rural and urban populations at two geographically distinct sites in India. The study will enrol 752 elderly individuals aged 60–80 years, receiving three or more medications for at least 6 months and having access to smartphones. The participants will be randomised to receive one of the following interventions for 12 months: control group, PRA, MPO and MPO+PRA. All study groups would receive patient education about the importance of medication adherence. The study outcomes include the proportion of improvement in medication adherence (using Medication Adherence Rating System-5, 7-day point prevalence of medication non-adherence and pill count); adverse clinical outcomes; healthcare utilisation; health-related quality of life; cost-effectiveness and cost-utility outcomes.

The study protocol has been approved by institutional ethics committees at all three institutes. The study results for primary and secondary outcomes will be published in peer-reviewed journals.

CTRI/2024/01/061975 (Registered on: 29 January 2024).

This study aimed to identify intraoperative and perioperative factors influencing 30-day mortality after cardiac surgery and to develop a risk score (POP-score) for its prediction.

Retrospective cohort study with multivariable regression analysis.

A tertiary care cardiac surgery centre in Austria; data from consecutive patients undergoing cardiac surgery between 2010 and 2020 were analysed.

A total of 8072 patients were included. The cohort was randomly divided into a derivation cohort (75%) and a validation cohort (25%).

The primary outcome measure was 30-day mortality. We analysed associations between intraoperative and perioperative variables and 30-day mortality, assessed via multivariable regression analysis.

Several factors were significantly associated with 30-day mortality, including intraoperative RBC transfusion (OR 3.407 (95% CI 2.124–5.464)), postoperative high-sensitive cardiac troponin T cut-off levels (OR 2.856 (95% CI 1.958 to 4.165)), need for dialysis/haemofiltration (OR 2.958 (95% CI 2.013 to 4.348)) and temporary extracorporeal membrane oxygenation support (OR 5.218 (95% CI 3.329 to 8.179)) (p

The validated POP-score provides an improved tool for predicting 30-day mortality after cardiac surgery by incorporating intraoperative and perioperative factors alongside the EuroSCORE II. Although model performance was evaluated using 7-day peak troponin data, the score can be calculated within the first 72 hours postoperatively in most patients, supporting its clinical applicability for early decision-making, resource allocation and patient counselling. Further research is warranted to assess its clinical utility in diverse populations.

About 30% of depressed patients suffer from a protracted course in which the disorder continues to cause significant burden despite treatment efforts. While originally developed for relapse prevention, mindfulness-based cognitive therapy (MBCT) has increasingly been investigated in depressed patients with such ‘difficult-to-treat’ courses. This is a protocol for an individual participant data (IPD) meta-analysis aiming to determine efficacy and potential moderators of MBCT treatment effects in this group based on evidence from randomised controlled trials.

Systematic searches in PubMed, Web of Science, Scopus, PsycINFO, EMBASE and the Cochrane Controlled Trials Register for randomised controlled trials were completed on 17 June 2024. Authors of identified studies have contributed IPD, and data extractions have been completed. An update search will be conducted immediately before the start of data analyses. We will investigate the following outcomes: (a) self-reported and observer-reported severity of depression symptomatology, (b) remission and (c) clinically meaningful improvement and deterioration. One-stage and two-stage IPD-MA will be conducted with one-stage models using the observed IPD from all studies simultaneously as the primary approach. One-stage IPD models will include stratified study intercepts and error terms as well as random effects to capture between-study heterogeneity. Moderator analyses will test treatment-covariate interactions for both individual patient-level and study-level characteristics.

The results will inform understanding of the use of MBCT in patients with current ‘difficult-to-treat’ depression and will contribute to arguments in favour of or against implementing MBCT as a treatment for this group. They will be published in a peer-reviewed journal and made available to stakeholders in accessible formats. No local ethical review was necessary following consultation with the Ethics and Governance Board of the University of Surrey. Guidance on patient data storage and management will be adhered to throughout.

CRD42022332039.

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.

Osteogenesis imperfecta (OI) is the most common inherited cause of bone fragility (approximately 1 in 16 000). People with OI suffer bone fragility causing fractures, pain and deformity; sarcopenia causing fatigue and poor endurance; aortic root dilatation and hearing loss. No drug currently has market authorisation to treat OI in Europe. Current standard-of-care is multidisciplinary, with pharmacological interventions—primarily bisphosphonates—directed at increasing bone mass; however, such interventions are of equivocal efficacy. The structural damage that can accumulate as a result of repeated fractures over time may not be reversible. The lack of a treatment with clearly defined efficacy in terms of reducing fracture frequency or the sarcopenia, that is increasingly recognised in this condition, leads to the consideration of alternatives based on what is known about the molecular pathophysiology of the condition. For reasons that are currently unclear, transforming growth factor beta (TGFβ) pathway signalling is increased in OI, and both studies in mouse models and more recently also in humans suggest that reducing TGFβ pathway signalling could be of benefit in OI. This demonstrator project tests the hypothesis that losartan, an antihypertensive agent known to reduce circulating TGFβ, will reduce bone turnover and bone loss and have a positive effect on muscle function and quality of life in adults and older adolescents with OI.

This is a phase 2/pilot, open-label, dose-escalating study. This study aims to identify the effective dose for losartan in this population to inform the design of a pivotal phase III study. The study aims to recruit 30 adolescents and adults aged 16 years and above with OI across secondary care study sites in the UK and Italy. Participants will be recruited from the patient populations attending for treatment of OI at the participating hospital sites or referred by clinicians at the Participant Identification Centres (PIC sites). Participants will be randomised to one of three ‘final doses’—25, 50 or 75 mg losartan once daily. All participants will start on 25 mg once daily. Those assigned to higher ‘final doses’ will increase in 25 mg once daily increments on day 8 and day 15 following safety assessments. The primary outcome measures are to establish the effective dose of losartan in OI patients, based on maximal reduction in the bone resorption marker carboxy-terminal crosslink of type I collagen telopeptide (CTX) over the 24-week period of the study.

Secondary outcome measures are to determine the changes in proxy efficacy outcomes for bone (turnover, mass, architecture and strength) using blood tests, high-resolution peripheral quantitative CT (HRpQCT), dual-energy X-ray absorptiometry (DXA) and muscle (strength) using the ‘Timed Up and Go’ test. In addition, the changes in quality of life, including pain and fatigue, will be evaluated by using a disease-specific tool (OI-QOL) and a validated generic tool (EQ-5D-5L-VAS).

In the UK, the study protocol and amendments have been approved by the London Bridge Research Ethics Committee (REC reference: 23/LO/015) and by the Medicines and Healthcare products Regulatory Agency (MHRA). In Italy, the study protocol and amendments have been approved by the Italian and European ethics and regulatory authorities (Clinical Trials Information System European Union (CTIS EU) portal according to EU Regulation 536/2014). Final version of study protocol: Version 3.2, 05.03.2025. Final results will be disseminated in peer-reviewed journals through local OI, orthopaedic and other relevant clinical networks and at national and international meetings. Sheffield Children’s National Health Service Foundation Trust (UK) and Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Ortopedico Rizzoli (Italy) are the joint study sponsors.

ISRCTN (ISRCTN13317811).

Research for pandemic response needs to be timely to inform evidence-based decision making. The lack of epidemiological data at the start of the COVID-19 pandemic led experts to call for cohorts that could rapidly supply data about newly emerging infectious diseases. The ‘Bern, get ready’ (BEready) study aims to establish a prospective ‘pandemic preparedness cohort’ in the canton of Bern, Switzerland. This cohort can be pivoted to the needs of a new pandemic pathogen. The aim of this pilot study was to investigate the potential response and to test the feasibility of procedures for BEready.

Closed population-based cohort study.

Random sample of private households in the canton of Bern, Switzerland, that had previously responded to an online survey.

Adults, children and pets.

Enrolment as a percentage, associations between the agreement to participate and the demographic and socioeconomic variables of the invited household member, number of social contacts, proportion of samples collected, proportion of complete questionnaires and proportion of participants responding after 12 months.

After the initial in-person visit with venous blood sampling, participants were followed up for 1 year. We tested remote data collection methods, with online questionnaires and self-collected capillary blood and nasopharyngeal samples, and established a biobank.

The pilot study enrolled 106/1138 (9%) of invited households plus two additional households that had proactively contacted us. In total, we enrolled 193 people in 108 households (1.8 per household) and 44 pets between April and September 2023. We obtained and stored at least one venous and/or capillary baseline blood sample from 184/193 (95%) people and 40/44 (91%) pets. After 1 year, 172/193 (89%) people in 101/108 (94%) of households completed a follow-up survey, as did 22 owners of 34/44 (77%) pets. 151/172 (88%) respondents returned a follow-up capillary blood sample.

The response rate to the pilot study shows that obtaining high levels of participant enrolment in a pandemic preparedness cohort study is challenging. Data collection without face-to-face contact with a study team is feasible for household members and will be needed in BEready if control measures during a pandemic prevent in-person studies.

To examine how menstruation, contraceptive use and gender-based violence intersect to shape the sexual and reproductive health and autonomy of girls and young women in Kenya.

Qualitative study exploring girls and young women’s experiences with contraceptive use and menstrual management, using in-depth interviews and focus group discussions analysed through a reflexive thematic approach.

Four county-run family planning clinics in Uasin Gishu County, Kenya.

77 girls and young women aged 15–19 years (via 35 in-depth interviews and 7 focus group discussions) and 27 family planning clinic providers (via 5 focus group discussions).

Interviewees’ contributions suggest that covert contraceptive use, when discovered through menstrual monitoring, provoked intimate partner violence. Heavy menstrual bleeding, whether related to contraceptive use or not, was viewed as a sexual restriction and also fuelled intimate partner violence. Furthermore, the inability to afford sanitary pads, combined with the stigma surrounding menstruation, drove some girls and young women into exploitative sexual relationships, often resulting in unwanted or unintended pregnancies.

Menstrual bleeding and contraceptive use, both independently and in combination, affect girls and young women’s reproductive autonomy and overall health and well-being, particularly in relation to gender-based violence. Improving menstrual hygiene management, challenging the stigma and harmful norms tied to menstruation and contraception and ensuring safe contraceptive use are integral to improving sexual and reproductive health and autonomy and are requisite for preventing and eradicating gender-based violence.