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PROspectiVe imaging research DEsign and coNducT (PROVIDENT): Considerations for clinical trials and studies using imaging (Part I)
Get PDFObjectives
Imaging is used in a wide range of contexts in clinical research projects, but adds complexity to the design, conduct and analysis. This paper is the first of two in which we use a consensus approach to bring together multidisciplinary perspectives on the challenges in conducting prospective clinical trials and research studies that include imaging. In this first part we consider challenges in ethics, participant information and consent, recruitment, trial/study and site set-up, training and trial or study conduct.
Key findings
Effective communication with patients regarding the purpose, benefits and risks, and potential future use of imaging data is essential to build trust and support informed participation. Transparency around data handling, including de-identification processes and the right to withdraw consent, underpins ethical research practice. Successful recruitment requires strong collaboration between clinical and imaging teams to ensure clarity, consistency, and efficiency. To reduce participant burden, flexibility should be offered in scheduling and scan requirements, taking into account accessibility and personal commitments. Site setup and staff training benefit from feasibility assessments that evaluate equipment capabilities and identify specific imaging training needs. Clearly defined roles and responsibilities of key personnel support streamlined workflows and accountability. Communication of planned changes to procedures during the study to all stakeholders is key to avoid delays and risks to data integrity. Effective monitoring of procedures, radiation doses (where applicable) and data quality should be pre-planned.
Conclusion
These considerations derived from a multidisciplinary team will be useful for funding applications, protocol design, trial implementation, conduct, commercialisation and uptake of new imaging techniques.
Implications for practice
Many prospective imaging studies could be improved by the upfront awareness of potential challenges and understanding of real-world examples these considerations provide
Is God’s creation a fictional world?
No full textAbstract: Samuel Lebens argues that we may understand God's act of creation by analogy with an author's creation of fictional characters. I argue that, in the relevant sense of "fictional characters" authors do not create such beings; rather, they invite us to imagine that such beings exist. I also argue that Leben's view would make authorship moral problematic in implausible ways. Along the way I briefly offer an account of the being of fictional characters and consider the relations between truth-in-fiction and truth
Measurement and management of adult blood pressure in the peri‐operative period: updated guidelines from the Association of Anaesthetists and the British and Irish Hypertension Society
Get PDFIntroduction
Maintaining stable blood pressure during surgery is a key responsibility of anaesthetists. Peri-operative omission and reintroduction of antihypertensive drugs, general anaesthesia, neuraxial and regional techniques can all cause significant fluctuations in blood pressure, particularly in patients with hypertension. Since the first edition of this guideline there has been more literature regarding peri-operative management, but some areas still lack standardisation.
Methods
This was a planned update of the 2016 guidelines from the Association of Anaesthetists and British Hypertension Society: The measurement of adult blood pressure and management of hypertension before elective surgery. An expert working party was convened. We conducted a targeted literature review followed by a modified Delphi process to formulate recommendations.
Results
We make recommendations on the management of blood pressure in the peri-operative period (from time of decision to operate until 30 days after surgery) for adults having planned surgery (excluding cardiothoracic, obstetric and endocrine surgeries). These include when and how to measure blood pressure; blood pressure thresholds for postponement of planned surgery; and the peri-operative management of blood pressure. Key recommendations include: secondary care peri-operative teams should accept patient referrals that document a clinic blood pressure measurement < 160/100 mmHg, or an ambulatory or home blood pressure measurement < 155/95 mmHg in the past 12 months; and patients who attend the pre-operative assessment clinic without documentation of normotension in primary care may proceed to elective surgery if their clinic blood pressure measurement is < 180/120 mmHg or ambulatory or home blood pressure measurement < 175/115 mmHg.
Discussion
Managing hypertension in the peri-operative period requires a nuanced approach, balancing immediate peri-operative risks with long-term cardiovascular health. Clear communication between primary care, hospital departments and patients is essential to minimise conflicting advice and ensure safe surgical outcomes
CGM‐derived efficacy and overall safety of once‐weekly insulin efsitora alfa (efsitora) relative to day of administration in adults with type 2 diabetes
Get PDFLongitudinal trajectories of CKD-associated pruritus
Get PDFIntroduction
Chronic kidney disease (CKD)-associated pruritus (CKD-aP) is a common and distressing symptom among dialysis patients, negatively affecting patient-reported outcomes (PROs) such as sleep and mental health. Despite its high prevalence, the evolution, incidence, and long-term impact of CKD-aP remains poorly understood. This study examined the cumulative incidence of new-onset CKD-aP among patients on hemodialysis (HD), identified its key predictors, and assessed associations between CKD-aP severity and PROs.
Methods
In this prospective, multicenter cohort study, incident and prevalent HD patients from 6 European countries were followed over 18 months, with assessments every 3 months. Patients completed an electronic PRO (ePRO) survey, including the Kidney Disease Quality of Life Short Form 36-Item short-form survey itchy skin item and measures of fatigue, sleep, depression, and general health. Sankey diagrams and Spearman’s correlations were used to describe pruritus evolution. Cox and linear regression models were used to identify predictors of moderate-to-severe pruritus and examined associations with PROs.
Results
Among 747 patients, the 18-month cumulative incidence of moderate-to-severe pruritus was 52%. Baseline–to–follow-up correlations for pruritus severity declined over time, though short-term correlations remained strong. Sociodemographic and clinical characteristics were minimally predictive of incident pruritus. Compared with those without pruritus, patients with incident pruritus reported higher fatigue (+0.7 [0.1–1.4]) and lower sleep quality scores (−1.0 [−1.6 to −0.5]). Similar patterns were observed for persistent versus resolved pruritus.
Conclusion
CKD-aP is a prevalent and fluctuating symptom in patients on HD. Its association with poorer fatigue and sleep outcomes highlights the importance of ongoing monitoring and targeted management to improve patient well-being
Novel hybrid magnet asymmetric rotors for electric vehicles
Get PDFThis paper proposes two novel hybrid magnet rotor topologies, spoke-V and spoke-delta, for interior permanent magnet synchronous machines (IPMSMs) for reducing rare-earth magnet usage while maintaining high electromagnetic performance in electric vehicles. Using the Tesla Model 3 IPMSM as a reference, the models are parametrized and multi-objective optimization is performed. The proposed spoke-V and spoke-delta configurations achieve NdFeB volume reductions of 19.4% and 25.8%, respectively, while matching the torque performance of the reference machine. This results in a 20.5% and 35.1% improvement in torque per unit volume of rare-earth material. Detailed electromagnetic analyses are conducted under open-circuit, peak-load, and torque-speed characteristic analysis under full operating conditions, demonstrating the feasibility of the proposed topologies for high-speed electric vehicle applications. A small-scale prototype is manufactured and tested to verify the accuracy of the calculations. These findings highlight the potential of asymmetric hybrid magnet rotor designs to deliver less rare-earth and high-performance IPMSMs, contributing to the development of more sustainable and cost-effective electric drive solutions
Mammalian herbivory indirectly shapes savanna arthropod communities but only at very low or high levels
Get PDFElectrostatic Patterning Controls Mineral Nucleation Inside Ferritin
No full textFerritin protein nanocages store iron across nearly all living organisms. In mammals, two subtypes of ferritin exist: heavy (H) chain and light (L) chain. They have very similar 3D structures, but each performs a slightly different role in iron mineral formation. How sequence differences between the two subtypes affect mineral formation within the nanocages is still unclear. Single-particle reconstruction of cryo-TEM images was used to build models of unmineralized and partially mineralized human L-chain and H-chain ferritin, which showed that subtle differences in protein structure led to changes in the location of mineral formation within ferritin. Explicit-solvent atomistic molecular dynamics (MD) simulations were used to explore how sequence-dependent electrostatics modulate ion transport, cluster formation, and mineral nucleation within the confined environment of human L- and H-chain apoferritin nanocages. Employing NaCl as a computational probe, we show that the internal charge distribution governs ion selectivity and nucleation pathways. Analysis of liquid and solid ionic clusters, combined with Markov State Models (MSMs), reveals that mineralization proceeds through a two-step mechanism involving dense liquid-like precursors that crystallize homogeneously within the cavity. These findings provide molecular insight into how ferritin sequence variability tunes confinement-driven nucleation and suggest general principles for designing biomimetic nanoreactors
ESPNet: Edge-Aware Feature Shrinkage Pyramid for Polyp Segmentation
No full textDespite numerous techniques developed for polyp segmentation, the issue of generalizability to new centers and populations persists. To address these issues, we compile a multicenter train set consisting of 4,000 polyp frames and propose a novel approach toward generalizing to different data centers, difficult polyp morphologies (e.g., flat or small), and inflammatory conditions such as inflammatory bowel disease (IBD). In this regard, we propose a transformer-based polyp segmentation model to leverage global contextual information, and enhancement of local feature interactions through a novel feature decoding and fusion method, and polyp edge features. This combines the vision transformers’ strong contextual understanding with enhanced locality modeling through graph-based relational understanding and multiscale feature aggregation. We compare our model with eight recent state-of-the-art methods under five widely used metrics on the following benchmark datasets: Kvasir-Sessile, SUN-SEG-Easy (Seen), ETIS-LaribPolypDB, CVC-ColonDB, PolypGen-C6, and our in-house IBD dataset. Extensive experiments show that our model outperforms state-of-the-art methods on out-of-distribution datasets with mIoU improvements of 2.84% on ETIS-LaribPolypDB, 1.26% on CVC-ColonDB, 1.90% on PolypGen-C6, and 3.52% on the in-house IBD polyp dataset compared to the most accurate recent method. The code is available at https://github.com/Raneem-MT/ESPNet
Primary health care networks and impacts in LMICs: A systematic review
No full textPrimary healthcare provider networks (PHCPNs) are increasingly recognized as promising strategies to effectively strengthen health systems in low- and middle-income countries (LMICs). However, there is limited information on the influence PHCPNs may have on the process and clinical outcomes of health services. This study sought to answer the questions: what is the extent, range and nature of research on PHCPNs in LMICs, what are the types of PHCPNs described, and what are the processes e.g. access to care, coverage of health services, quality of care and services, safety of care and the clinical care outcomes of PHCPNs reported in the published literature? We report on a systematic mixed-methods review on PHCPNs as a strategy to strengthen health systems in LMICs following the PRISMA guidelines. The quality of the included studies was assessed using the ROBINS-I and Mixed Methods Appraisal tools, while a narrative synthesis was employed to describe the results. Fifteen primary studies were found eligible for the review. From the included papers, eight types of PHCPNs were identified across various contexts and countries. We found that the PHCPNs primarily focus on maternal, newborn, and child health outcomes. The study reveals that: (1) PHCPNs contribute to improvements in the process outcomes of health services by enhancing access to care, coverage of health services, quality of care and services, and safety of care, and (2) they support improvements in clinical outcomes by helping to reduce maternal, neonatal, and perinatal mortalities and stillbirths. This body of literature we reviewed suggests that PHCPNs make a difference in the process and clinical outcomes of health services in LMICs. This review serves as both a mapping and clarification exercise to promote the adoption of PHCPNs and as a foundation for further research, especially in areas of health services beyond maternal, newborn, and child health
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