Clinical Research Research Articles

QLTI-07. COLLABORATIVE RESEARCH SUITE FOR GENOMIC ANALYSIS, DATA REPORTING AND WORKFLOW CUSTOMISATION

Abstract The genomic analysis pipeline involves multiple stages, including data extraction, transformation, and loading (ETL), exploratory data analysis (EDA), machine learning (ML) modeling, and reporting. The ETL stage involves data profiling and quality control measures to ensure data integrity and consistency. The EDA stage employs statistical and visualization methods to understand data distribution, identify patterns, and detect anomalies. Machine learning modelling involves supervised classification techniques, such as logistic regression and support vector machines (SVMs), to predict tumour classification and develop gene signatures. Unsupervised classification techniques, such as K-means clustering and Hierarchical clustering, identify patterns and relationships in genomic data. Quality metrics evaluate data completeness, accuracy, and consistency, ensuring data reliability and validity. The integration of data science techniques into a comprehensive framework can be achieved with the development of Application Dashboards that provide real-time insights into genomic data across every stage of the analysis pipeline. This enables clinical researchers and bioinformaticians to make informed decisions quickly, improving turn-around time and accelerating the discovery of new insights. In contrast to conventional methods of using stand-alone scripts, these dashboards offer a reusable and scalable solution, allowing for easy modification and adaptation to new datasets and analysis pipelines, thereby reducing development effort and increasing productivity. The dashboards constitute a centralized platform for data visualization, exploration, and analysis, facilitating collaboration and communication among research team members. With customizable and interactive visualizations, users can explore genomic data from multiple dimensions and the integration of multiple sources, including genomic and transcriptomic data. The technologies used to power this Research suite include Streamlit for Web App development, Python for data analysis, Opensearch for data storage and other utility libraries for reporting.

Causal impact of gut microbiota on five liver diseases: insights from mendelian randomization and single-cell RNA sequencing

BackgroundLiver disease is among the top ten causes of death globally. With studies suggesting a link between gut microbiota (GM) and liver disease.MethodWe selected summary statistics data from the largest available whole-genome association study (n = 13,266) of GM by the MiBioGen consortium as the exposure, and obtained liver disease-related data from IEU Open GWAS and The NHGRI-EBI GWAS Catalog. A two-sample Mendelian Randomization (MR) analysis employing various methods, to establish the causal relationship between GM and five liver diseases. Meanwhile, single-cell RNA sequencing data were used to examine Prevotella-related genes expression under healthy and disease liver.ResultsThe IVW analysis indicate a causal relationship between GM and liver diseases, with Prevotella exhibiting a protective effect in all five liver diseases: Alcoholic liver disease (OR:0.81,95% confidence interval:0.66-1.00,PIVW = 0.0494); Cirrhosis (OR: 0.85,95% confidence interval: 0.73-0.99,PIVW = 0.0397); Hepatic failure, not elsewhere classified (OR:0.60,95% confidence interval:0.37-0.95,PIVW = 0.0305); Benign neoplasm:Liver (OR:0.39,95% confidence interval:0.2-0.75,PIVW = 0.0046); Malignant neoplasm of liver, primary (OR:0.41, 95% confidence interval:0.18-0.93,PIVW = 0.0334). The single-cell results suggest differential expression of Prevotella-related genes between liver disease patients and healthy individuals.ConclusionOur MR results show a causal relationship between the GM and liver disease. Prevotella displays a notable protective effect. This finding may enhance the precision of GM-based therapies and offer new insights for clinical research.

The Emergence of Saliva as a Diagnostic and Prognostic Tool for Viral Infections

Saliva has emerged as a promising diagnostic fluid for viral infections, enabling the direct analysis of viral genetic material and the detection of infection markers such as proteins, metabolites, microRNAs, and immunoglobulins. This comprehensive review aimed to explore the use of saliva as a diagnostic tool for viral infections, emphasizing its advantages and limitations. Saliva stands out due to its simplicity and safety in collection, along with the convenience of self-collection without the need for healthcare supervision, while potentially being comparable to urine and blood in terms of effectiveness. Herein, we highlighted the significant potential of saliva in assessing viral loads and diagnosing viral infections, such as herpesviruses, HPV, PyV, TTV, SARS-CoV-2, and MPXV. The detection of viral shedding in saliva underscores its utility in early diagnosis, the monitoring of infection progression, and evaluating treatment responses. The non-invasive nature of saliva collection makes it an appealing alternative to more invasive methods, promoting better patient compliance and facilitating large-scale screening and surveillance. As such, we further highlight current evidence on the use of saliva as a prognostic tool. Although a significant amount of data is already available, further investigations are warranted to more comprehensively assess the added benefit from the utilization of salivary biomarkers in the clinics. Salivary biomarkers show great promise for the early detection and prevention of viral infection complications, potentially improving disease management and control at the population level. Integrating these non-invasive tools into routine clinical practice could enhance personalized healthcare strategies and patient outcomes. Future studies should focus on establishing standardization protocols, validating the accuracy of salivary diagnostics, and expanding clinical research to enhance the diagnostic and monitoring capabilities of salivary biomarkers.

PATCH (Preferred Attachment Strategy for Optimal Electrocardiograms)-1 Study.

12-Lead electrocardiography (ECG) is among the most frequently performed tests in medical practice. Despite its pivotal role in diagnostic and treatment decisions, baseline artifacts and errors in lead placement are common. The PATCH (Preferred Attachment Strategy for Optimal Electrocardiograms)-1 study enrolled patients with stable cardiovascular disease and a clinical indication for an ECG. Each participant underwent both a standard (S) 12-lead ECG and a patch (P) ECG (EKG-Patch™) during one routine ambulatory clinic visit. The P-ECG has an all-in-one design with built-in lead wires attached to pre-positioned electrodes. An experienced clinical research coordinator performed all ECGs. Each was interpreted by an experienced cardiologist blinded to the method of ECG. A total of 200 participants (67.4 ± 14.9years; range: 21-95years) (women 44%) had P- and S-ECGs. Common clinical indications included coronary artery disease (40.5%), essential hypertension (14.0%), heart failure (10.5%), atrial fibrillation (10.0%) and valvular heart disease (6.5%). Many participants had more than one indication. The P-ECG provided a tracing in 1.4 ± 0.5min compared to 2.4 ± 0.5min with the S-ECG (p < 0.001). Most participants either preferred the P-ECG (47%) or did not have a preference (52%). Baseline artifacts that impacted interpretability were detected in 13 (6.5%) P-ECGs and 30 (15.0%) S-ECGs (p = 0.006). Heart rhythm, rate, conduction, axis, intervals (PR, QRS, QT, and QTc) and ST-T wave findings did not differ between P-and S-ECGs. In conclusion, the P-ECG was preferred among participants, had fewer baseline artifacts than the S-ECG, and provided a rapid and reproducible ECG in patients with stable cardiovascular disease in an ambulatory clinic setting.

DISP-09. IMPROVING ADHERENCE TO CANCER CARE IN UNDERSERVED PATIENTS WITH CENTRAL NERVOUS SYSTEM TUMORS

Abstract Patients with central nervous system tumors have disease-specific symptoms such as aphasias, motor symptoms, neuropsychiatric symptoms, or seizures that make treatment adherence difficult. This is further exacerbated by the social determinants of health – patients from historically marginalized groups or those with lower socioeconomic status have additional barriers to treatment. The Integrated Cancer Care Access Network (ICCAN) is a multi-institutional patient navigation program assisting patients who express socioeconomic needs during cancer treatment. In this pilot program, we assessed the impact of ICCAN on treatment adherence and quality of life of CNS cancer patients from marginalized backgrounds. 42 participants with primary brain tumors or brain metastases were recruited from inpatient and outpatient services at Memorial Sloan Kettering Cancer Center to enroll in ICCAN-CNS. Patients were eligible if they were 18 years or older, receiving active treatment or under active surveillance, and screened positive for an essential need. Through standardized patient interviews and questionnaires, we evaluated their needs such as food access, housing, and financial needs. The clinical research coordinator interviewed the patients via phone, taking approximately 60 minutes. The interviews comprised an Essential Needs Assessment, Health Related Social Needs Assessment, NCCN Distress Thermometer, and an ICCAN-CNS questionnaire focused on neurology-specific symptoms. Caregivers helped complete the questions for patients with cognitive impairments. Patients were then matched with resources based on their initial needs assessment. The interviewer conducted 2, 4, and 6-month follow-ups to see if new needs emerged for which resources were provided. Response to the program was overwhelmingly positive with many patients expressing gratitude for the resources provided to them. This pilot demonstrates the feasibility of CNS tumor patients participating in the ICCAN intervention and the need for additional patient navigation programs and interventions that focus on the social determinants of health.

Through Their Eyes: Using Photovoice to Capture the Capacity-Building Journey of Long Covid Patient Experts.

Long Covid, characterised by persistent symptoms following the coronavirus disease 2019 (COVID-19) infection, significantly impacts the quality of life. Engaging patients in research and care through participatory methods can enhance a shared understanding of illness and improve the relevance of research. We define Patient Experts (PEs) as persons (including patients, caregivers and providers) who have completed a series of training sessions on team building, research methods and communication at the Patient Engagement Studio, University of South Carolina (PES USC). This study explores the use of photovoice to document the experiences and capacity-building journey of Long Covid PEs within PES USC. The study employed photovoice within the COVID-19-Focused Virtual Patient Engagement Studio (CoVIP Studio). PEs submitted photographs and narratives at two distinct time points. Among the 18 PEs who participated in the project, 47 photos were collected during the training, and 31 were collected at the project's conclusion. Thematic analysis was conducted to capture changes in patient perspectives and engagement. Initial themes identified were "Hope through Community," "Collaborative Education and Research" and "Strength and Endurance." By the project's end, themes had evolved to "Working as a Team to Share and Acquire Knowledge," "Enhanced Confidence in the Future of Care" and "Perseverance and Progress." These findings highlight the transformative impact of patient engagement and the utility of photovoice in documenting longitudinal shifts in patient perspectives. Photovoice effectively engaged Long Covid patients and captured their evolving roles and perceptions as PEs. The study underscores the value of patient-led participatory methods in enhancing the relevance and applicability of clinical research, advocating for their broader adoption to improve patient-centred care and research outcomes. A CoVIP Studio stakeholder advisory board (CoVIP SAB) guided the co-development and implementation of this project. The CoVIP SAB comprised nine members with complementary skills and expertise, including three patients, three clinicians who provide care to patients with COVID-19 and three researchers with expertise in patient-centred research, COVID-19 and/or patient engagement and collaborate with patients as co-investigators. The board contributed to project design and implementation, refining photovoice prompts and shaping dissemination strategies. In addition, one PE who actively participated in all phases of the project contributed to the writing of this paper and is a coauthor. All project activities involved patients and/or caregivers with lived experience of Long Covid.

Research Situation, Hotspots, and Global Trends in Laser Treatment of Acne Scars: A Bibliometric Analysis of Related Research From 2014 to 2024.

Acne vulgaris is a chronic inflammatory skin condition, commonly resulting in acne scars. Treating acne scars remains a significant challenge in dermatology. With advancements in laser technology, its clinical use for treating acne scars has been increasing annually. However, bibliometric analysis on laser treatment for acne scars is lacking. This study aims to use bibliometrics to comprehensively understand the development trends and research hotspots in laser treatment for acne scars. Using "acne scar" and "laser" as search terms, literature on laser treatment of acne scars from 2014 to 2024 was retrieved from the Web of Science Core Collection (WoSCC) database. The literature data were visualized using VOSviewers, CiteSpace, and R software, generating maps of countries, research institutions, authors, journals, references, and keywords. The analysis included 536 articles from 46 countries, with the United States and China leading in publications. Publications focusing on laser treatment of acne scars exhibit a consistent growth trend annually. Key research institutions include Mahidol University in Thailand, Cairo University in Egypt, and Hallym University in South Korea. The "Journal of Cosmetic Dermatology" had the highest number of articles in this field, while "Dermatologic Surgery" was the most cited publication. These publications involved contributions from 2135 authors, with Professor Manuskiatti Woraphong from Mahidol University in Thailand being the most prolific author in this field. Research on the efficacy of laser treatment for acne scars is a major focus in this field. Among the different types of lasers, CO2 lasers are the most commonly used. Emerging research focuses include therapies such as platelet-rich plasma, picosecond laser, trichloroacetic acid, and burn scar. Treatment efficacy is the primary focus of research in the field of laser treatment for acne scars. Platelet-rich plasma, and novel picosecond lasers, have emerged as hot topics and trends in this research field. However, it is important to note that the impact factors of journals publishing in this field are currently low. Therefore, clinicians must consider and explore strategies for publishing high-quality clinical research in the future.

Evaluating biosimilars: safety, efficacy, and regulatory considerations in clinical studies.

Biosimilars are a rapidly growing area of clinical research, yet they encounter significant challenges, especially in emerging markets where regulatory and clinical hurdles differ markedly from those in established regions like Europe and the US. This commentary addresses these unique challenges and offers new perspectives on the global adoption of biosimilars. It emphasizes the crucial role of real world evidence in supporting biosimilar approvals, an aspect often underrepresented in current literature. The commentary also provides a comparative analysis of the regulatory frameworks in China and Europe, highlighting how these differences shape biosimilar development and market approval processes. By focusing on the issues of indication extrapolation and immunogenicity, this commentary highlights the necessity of continuous real-world data collection to ensure the safety and efficacy of biosimilars across multiple indications. Our analysis enhances the understanding of biosimilar research and supports their broader adoption as safe, effective, and accessible healthcare solutions globally.

QLTI-09. CLINICAL TRIALS IN NEURO-ONCOLOGY: DESIGN, LOGISTICS, CHALLENGES, AND PRACTICAL CONSIDERATIONS

Abstract Timely, secure and reliable transportation, precise handling and storage of biological specimens are critical for the success of clinical research. Research in neuro-oncology often involves complex assays such as next-generation sequencing where the integrityof brain tumor specimens is paramount. These challenges are pronounced in most Lower Middle-Income Countries (LMIC), due to climatic factors and infrastructure limitations, necessitating stringent measures to preserve sample quality and their genetic data integrity for downstream analysis. In this study, we conducted extensive cohort analysis on 80 tissues randomly picked samples of the 3600 samples collected across India to assess the impact of collection protocols, transportation logistics, and long-term storage on the genetic material of tissues. The quality and quantity of the isolated nucleic acids was determined by BioAnalyzer and Qubit parameters. Tissue samples were collected and stored at -80°C in RNAstable® within 4-12 hrs of collection. The DNA and RNA obtained from tissue samples stored for over one year was found to be of good quality with corresponding DNA Integrity Number (DIN) and RNA Integrity Number (RIN)between 7-9. Also, optimum quantity of DNA and RNA was obtained for whole exome and transcriptome sequencing. Upon sequencing, these samples showed good read coverage of 100X or more. These findings provide critical insights into the measures necessary for optimizing sample preservation and transportation to ensure accurate research outcomes. The results indicate that appropriate sample collection, transportation, and long-term storage of bio-specimens can be used effectively for future research. Additionally, the outcome underscores the potential for long-term studies in neuro-oncology using archived biological samples without compromising data integrity.

The ethical inadequacy of uninformed surrogate consent: advancing respect for persons in clinical research.

In clinical research, decision-making capacity is often equated with unspecified conceptions of autonomy, and autonomy is often equated with personhood. On this view, the loss of decision-making capacity is seen as a loss of autonomy, and the loss of autonomy subsumes a loss of personhood. An ethical concern arises at the intersection of those philosophical considerations with the legal considerations in informed consent. Because persons with inadequate decision-making capacity cannot provide legally effective consent, enrollment in research can occur only if a surrogate gives permission on the person's behalf. Federal regulations and resulting institutional policies allow permission from surrogates empowered under state law to consent to medical treatment procedures, typically in a hierarchy of legislatively prioritized relationships lacking regard for what the surrogate actually knows about the current research-related values and preferences of the potential subject. As a result, the research enterprise often countenances reliance on surrogates who have no relational or informational basis for an enrollment decision that aligns with the values and preferences of the subject. Arguing from the perspective that losing decision-making capacity does not alter the moral status of persons, and that respect for persons rather than respect for autonomy is the central ethical obligation, I assess the ethical implications of allowing persons with no knowledge of the values and preferences of the potential subject to make enrollment decisions, concluding that reliance on uninformed surrogates is not an ethically defensible approach to enrolling subjects in clinical research.

DocNER: Document Chat Assistance with NER

The increasing amounts of high volume unstructured medical data, such as research and clinical articles, impede efficient information extraction. Since the medical texts have a complex structure, many times these approaches do not work, leading to significant losses. The current approaches are not robust to a wide spectrum of medical content as they are too specific to the given domain.This study proposes a recent innovative approach that involves the combination of Named Entity Recognition (NER) and Retrieval-Augmented Generation (RAG) to enhance entity extraction and give useful bibliographic information from medical data respectively. The objectives of our method are to improve accuracy, accommodate different kinds of documents, and assist in clinical research and patient care.

Evidence-based veterinary medicine-potential, practice, and pitfalls.

Understanding and incorporating evidence-based veterinary medicine (EBVM) into clinical practice and research continues to pose a challenge for our profession despite over 2 decades of increasing awareness of this concept. Reasons for this include a lack of understanding of its importance to the practice of medicine, veterinary literature that often fails to adhere to evidence-based standards, inadequate attention to teaching EBVM at the university level, and the inherent reluctance of clinicians to alter historical practice styles. For many practitioners, EBVM continues to be an abstract concept they believe requires advanced training in statistics and epidemiology resulting in them relying on less robust sources for clinical guidance. This unfortunately results in suboptimal care for our patients and delayed medical advancements for our profession. As part of the 20th anniversary of the founding of the Evidence-Based Veterinary Medicine Association (EBVMA), we are refocusing our efforts to highlight the need for dedicated teaching of EBVM at the university level, for rigorous adherence to established research reporting guidelines, for expansion of EBVM infrastructure, and for the provision of easily accessible tools that permit clinicians to incorporate EBVM into their daily practice. As the quality of veterinary literature improves, so too will development of more effective clinical practice guidelines that ultimately can be widely adopted if they are flexible enough to support the triadic relationship between veterinarians, our clients and our patients. Ultimately, EBVM is not an end unto itself, but rather a means to improve the quality of care we provide our patients.

Achieving Inter-Rater Agreement and Inter-Rater Reliability to Assess Fidelity of an Occupation-Based Coaching (OBC) Clinical Trial Intervention

Introduction: Establishing inter-rater agreement and reliability ascertains that multiple raters consistently evaluate observed interventions to ensure that clinical research protocols are delivered as intended by the trial protocol. Purpose: Using the Guidelines for Reporting Reliability and Agreement Studies, we (a) exemplified the steps to establish inter-rater reliability and inter-rater agreement on the occupation-based coaching Video Evaluation Tool and (b) evaluated best practices that promoted high inter-rater reliability and inter-rater agreement between blinded raters prior to starting a pilot randomized controlled trial. The randomized controlled trial examined the preliminary effectiveness of occupation-based coaching via telehealth for rural families with children living with type 1 diabetes to improve family quality of life, participation, self-efficacy, and child health outcomes. Method: We created a library of 13 occupation-based coaching videos portraying a range of evaluations, scores, and ratings. The inter-rater agreement and reliability on the occupation-based coaching Video Evaluation Tool were established through the iterations of (a) blinded rater training, (b) data collection using the tool, and (c) statistical analysis using Cohen’s kappa and Cronbach’s alpha. Findings: Occurrence and Non-Occurrence Checklist (κ = 0.881, p &lt; 0.001); “Caregiver Talk” and “Interventionist Talk Analysis” (ICC = 0.991–0.999, p &lt; 0.001); Evidence of Independent Capacity Rating (ICC = 0.867 p = 0.006). Conclusion: Strong inter-rater reliability and inter-rater agreement was established by engaging two blinded raters through multifaceted training, integrating real-life clients and contexts into the instrumentation and training, and precisely defined rubric criteria. By employing such practices, high inter-rater reliability and agreement can be achieved in clinical research involving interventions and instruments that are highly subjective and individualized. To ascertain greater scientific confidence in the intervention effect, developing a multidomain fidelity framework and establishing high inter-rater agreement and reliability in the instruments a priori to implementation of clinical trials are necessary.

Efficacy and safety of acupuncture for pain relief: a systematic review and meta-analysis.

This study aims to evaluate the efficacy and safety of traditional acupuncture for pain relief based on rigorously designed RCTs with double-blind. The findings seek to provide valuable insights for clinical practice and inform future research. A literature search was conducted in PubMed, Web of Science, Cochrane Library, and Embase databases for randomized controlled trials on traditional acupuncture for pain management using a double-blind design, published from database inception to November 22, 2023. The Risk of Bias 2 (RoB2) tool was used to assess potential biases in the included studies, followed by a comprehensive analysis to evaluate efficacy and safety. The findings show a significant positive effect on pain improvement, evidenced by changes in visual analog scale scores (mean difference 0.97 [95% confidence interval (CI) 0.66-1.27]). Safety analysis showed no significant differences in adverse reactions between the acupuncture and control groups (relative risk 1.40 [95% CI 0.52-3.74]), with no serious adverse effects reported. Traditional acupuncture is effective and safe in pain management. This suggests that acupuncture can be a valuable approach in clinical practice. Future studies should explore optimal treatment durations and frequency, using larger sample sizes for more comprehensive insights.

A new trial monitoring plan (TMP) template for clinical trials: output from a Delphi process

BackgroundMonitoring is a crucial part of trial conduct and ensures that participants’ data is fairly represented, and future healthcare information is enhanced. This project aims to improve trial monitoring by creating a trial monitoring plan (TMP) template with input from individuals experienced in monitoring clinical trials.MethodsA review of monitoring plans received from UK Clinical Research Collaboration (UKCRC) registered clinical trials units (CTU)s created the basis for a preliminary TMP template and a Delphi survey. The TMP template was finalised after 2 rounds of a Delphi survey and a two-part consensus meeting including trialists with experience and expertise in monitoring clinical trials.ResultsWe received 31 monitoring plans from UKCRC-registered CTUs and reviewed over 800 monitoring items for inclusion in a TMP template, selecting items based on guidelines such as Good Clinical Practice (GCP) and our monitoring experiences. For certain items, further expert input was required. A total of 66 items were chosen for a Delphi survey involving 47 participants from 25 UK CTUs and industry. After the first round, all 66 items were retained, and six additional items were suggested by Delphi participants. In the second round, 37 items reached consensus for inclusion in the TMP template. The Delphi process was followed by a consensus meeting with 9 participants from 9 UK CTUs and industry. Participants in the consensus meeting voted on the 32 further items that had not reached the definition of consensus within the Delphi, regarding each item’s inclusion in or exclusion from the TMP template. The voting resulted in 18 items being excluded, leaving 14 items to be included in the TMP template. The process overall resulted in a standardised TMP template with input from many individuals with interest, experience, or expertise in monitoring clinical trials.ConclusionA TMP template was developed building on the currently used monitoring plans and with input from those experienced in clinical trial monitoring. Using a centrally developed good quality TMP template should contribute towards maintaining consistency in monitoring standards across all CTUs, resulting in higher research quality and improved quality assurance. Its use should provide reassurance to participants that their participation is carefully monitored to ensure that their data or any samples provided are treated with confidentiality, integrity, and respect and that their rights and well-being are protected.

Service evaluation of the research outputs for 23/24 at a large London teaching hospital

Abstract Introduction The recent report of a UK survey of pharmacy professionals’ involvement in research1 found only small numbers of the pharmacy workforce are currently undertaking research. A number of reasons for this are identified and the report contains a list of recommendations to support the embedding of research into pharmacy careers.1 Within the pharmacy department at King’s College Hospital NHS Foundation Trust (KCH) all research proposals are presented at the pharmacy research and audit group and a log is kept of department research outputs by the clinical academic research lead. The analysis of this data will provide a benchmark. For the purposes of this study, research encompasses audit, service evaluation and research studies as defined by the Health Research Authority defining research table.2 Aim To identify, over the financial year 23/24, the frequency of different types of research outputs from the pharmacy department at KCH broken down by output type, specialty and role. Methods Regular emails were sent April 23 – March 24 to remind staff to identify and share research outputs with the clinical academic research lead. Outputs received were circulated by newsletter to encourage and motivate others. The clinical academic research lead engaged with individual pharmacy teams throughout the year to encourage and support research outputs. Research output data was collected, April 23 – March 24, on an Excel spreadsheet including staff name, role, specialty, type of research output and date the output was completed. Research outputs were categorised into published articles, published abstracts, attendance at conference, abstracts presented at conference and presentations at conference or national webinar. Ethics was not required as the study is defined as a service evaluation. Results There were a total of 89 research outputs by the pharmacy department across the year. These were broken down into published articles (20), published abstracts (16), attendance at conference (24), abstracts presented at conference (26) and presentations at conference or national webinar (3). The two specialty teams who produced or took part in the most research outputs over the year were critical care (15) and liver (11). Consultants pharmacists were involved in the most research activity (32) followed closely by principal pharmacists (26), specialist pharmacists (25) and the deputy chief pharmacists (19). Pharmacy technicians, pharmacists taking part in the STEP programme and non-registered pharmacy staff scored the least in terms of research activity relative to size of staff group. Consultant pharmacists and principle pharmacists were the groups that published the most articles (8 each). Discussion and conclusion The trust implemented a new electronic patient record system during the year which may have impacted the number of research outputs. A limitation to this study is that there are likely to be unrecorded research outputs. The data broken down by specialty and role will allow the pharmacy management group and clinical academic research lead to support, engage and motivate in those areas to allow staff to have the time, skills and guidance to carry out research activities. The results can be used by other healthcare organisations to benchmark against.

Neural mechanisms underlying robust target selection in response to microstimulation of the oculomotor system.

Despite its prevalence in studying the causal roles of different brain circuits in cognitive processes, electrical microstimulation often results in inconsistent behavioral effects. These inconsistencies are assumed to be due to multiple mechanisms, including habituation, compensation by other brain circuits, and contralateral suppression. Considering the presence of reinforcement in most experimental paradigms, we hypothesized that interactions between reward feedback and microstimulation could contribute to inconsistencies in behavioral effects of microstimulation. To test this, we analyzed data from electrical microstimulation of the frontal eye field of male macaques during a value-based decision-making task and constructed network models to capture choice behavior. We found evidence for microstimulation-dependent adaptation in saccadic choice, such that in stimulated trials, monkeys' choices were biased toward the target in the response field of the microstimulated site (Tin ). In contrast, monkeys showed a bias away from Tin in non-stimulated trials following microstimulation. Critically, this bias slowly decreased as a function of the time since the last stimulation. Moreover, microstimulation-dependent adaptation was influenced by reward outcomes in preceding trials. Despite these local effects, we found no evidence for the global effects of microstimulation on learning and sensitivity to the reward schedule. By simulating choice behavior across various network models, we found a model in which microstimulation and reward-value signals interact competitively through reward-dependent plasticity can best account for our observations. Our findings indicate a reward-dependent compensatory mechanism that enhances robustness to perturbations within the oculomotor system and could explain the inconsistent outcomes observed in previous microstimulation studies.Significance Statement Electrical microstimulation has been used to study the causal contributions of certain brain areas or circuits to cognition and behavior. Nonetheless, the overall impact of microstimulation on behavior remains inconclusive, hinting at neural mechanisms that interact with experimental perturbation of neural activity. We hypothesized that this interaction could be driven by the reward feedback animals receive while performing tasks, either with or without external perturbations. Using computational modeling and data from microstimulation during a reward-dependent decision-making task, we found microstimulation and reward-value signals competitively interact within the oculomotor system. This interaction enhances the system's robustness to both internal and external perturbations. Our results have important implications for employing microstimulation in basic and clinical research.

The effect of home exercises with kinesiotaping on pain, functionality, and work performance in bus drivers with non-specific neck pain.

Clinical research on the management and rehabilitation of work-related upper spinal pain in bus drivers is sparse, indicating a gap in knowledge and treatment strategies. This highlights the growing need for innovative approaches to rehabilitation programs in this area. To examine the effects of kinesio taping (KT) on pain, functionality, and work performance in bus drivers experiencing neck pain. The study involved 44 participants who were randomised into two different groups: the exercise group (n= 22) and the kinesio tape group (n= 22), with participants in both groups undertaking exercise interventions. Evaluations were made before and after 6 weeks of treatment. At the end of the 6-week, the participants' ROM, pain evaluations and functional scales were evaluated with disability, and work functionality. Neck pain severity decreased in both groups (p< 0.001 for each value), but there was no difference between the groups (p: 0.071). When disability scores were evaluated, improvement was noted in both groups (p: 0.001 for each value), but no statistically significant difference was found (p: 0.754). When the improvements in ROM values before and after the treatment were examined, the difference between the groups was recorded only in the neck extension ROM value (p: 0.011). Significant improvement was noted in all sub-steps of job performance in both groups (p< 0.05). KT added to ergonomic training and home exercise programmes is effective in controlling work-related musculoskeletal pain in drivers with neck pain. However, the addition of KT to exercise therapy was found to be no more effective than exercise therapy alone in improving pain control, functionality and work performance.

External Validation of Accelerometry-Based Mechanical Loading Prediction Equations

Accurately predicting physical activity-associated mechanical loading is crucial for developing and monitoring exercise interventions that improve bone health. While accelerometer-based prediction equations offer a promising solution, their external validity across different populations and activity contexts remains unclear. This study aimed to validate existing mechanical loading prediction equations by applying them to a sample and testing conditions distinct from the original validation studies. A convenience sample of 49 adults performed walking, running, and jumping activities on a force plate while wearing accelerometers at their hip, lower back, and ankle. Peak ground reaction force (pGRF) and peak loading rate (pLR) predictions were assessed for accuracy. Substantial variability in prediction accuracy was found, with pLR showing the highest errors. These findings highlight the need to improve prediction models to account for individual biomechanical differences, sensor placement, and high-impact activities. Such refinements are essential for ensuring the models’ reliability in real-world applications, particularly in clinical and biomechanical research contexts, where accurate assessments of mechanical loading are critical for designing rehabilitation programs, injury prevention strategies, and optimizing bone health interventions.

Year in Review 2023: Gout Clinical Research

Gout is the most common inflammatory arthritis, with a growing global disease burden. This conference report summarizes nine impactful publications dating from 11/2022 to 10/2023 to inform and improve clinical care in gout. The articles we present here collectively address diverse facets of gout research, including gout epidemiology, predictive biomarkers, the occurrence of complications relating to gout flares, and gout management strategies.