Clinical Science Research Articles

Bringing platform trials closer to reality by enabling with digital research environment (DRE) connectivity

Platform trials are generally regarded as an innovative approach to address clinical valuation of early stage candidates, regardless of modality as the evidence evolves. As a type of randomized clinical trial (RCT) design construct in which multiple interventions are evaluated concurrently against a common control group allowing new interventions to be added and the control group to be updated throughout the trial, they provide a dynamic and efficient mechanism to compare and potentially discriminate new treatment candidates. Their recent use in the evaluation of new therapies for COVID-19 has spurred new interest in the approach. The paucity of platform trials is less influenced by the novelty and operational requirements as opposed to concerns regarding the sharing of intellectual property (IP) and the lack of infrastructure to operationalize the conduct in the context of IP and data sharing. We provide a mechanism how this can be accomplished through the use of a digital research environment (DRE) providing a safe and secure platform for clinical researchers, quantitative and physician scientists to analyze and develop tools (e.g., models) on sensitive data with the confidence that the data and models developed are protected. A DRE, in this context, expands on the concept of a trusted research environment (TRE) by providing remote access to data alongside tools for analysis in a securely controlled workspace, while allowing data and tools to be findable, accessible, interoperable, and reusable (FAIR), version-controlled, and dynamically grow in size or quality as a result of each treatment evaluated in the trial.

Abstract PO4-19-03: FES-PET/MRI for Tailored treatment of luminal A and lobular breast cancer: a prospective cohort study

Abstract Background: Breast cancer (BC) staging is essential to planning the most appropriate treatment pathway. Currently, BC management has become more tailored to the tumor’s and patient’s characteristics. However, BC imaging shows varying performance according to tumor subtypes. In particular, routine imaging may pose some challenges when evaluating luminal A BC (LumA) and lobular BC (Lob). LumA, due to low grade and proliferation index (< 20%) shows lower sensitivity on axillary US, reduced MRI enhancement, and low FDG-avidity on PET. Similarly, Lob, due to its peculiar single-cell growth pattern, exhibits inferior sensitivity on axillary MRI and FDG-avidity. LumA and Lob account for >50% of all BCs. Despite their favourable prognosis, metastases and recurrences still occur; this translates into a higher absolute number of events than in other subtypes. As a result, a concrete risk of disease underestimation and under-treatment exists. Two ongoing studies on FDG-PET/MRI imaging in our institution have already demonstrated that its sensitivity also decreases in LumA and Lob. Based on these premises, our hypothesis states that by combining the advantages of hybrid PET/MRI with the high accuracy of 16α -18F-fluoro-17-beta-estradiol(FES), a radiolabeled form of estrogen binding to functionally active ER, we could obtain a reliable, non-invasive, operator-independent, one-stage imaging method for staging LumA and ER-positive Lob. Trial design: This is a prospective cohort study where patients with LumA and ER-positive Lob will be enrolled in four cohorts undergoing: A) primary surgery; B) induction endocrine therapy; C) neoadjuvant chemotherapy, and D) systemic therapy for metastatic disease. FES PET/MRI examinations will be performed at baseline for local and systemic staging in all cohorts and a second exam after systemic therapy in cohorts C-D. Correlations between the FES PET/MRI parameters and pathology, gene expression, and FDG PET parameters, when available, will be investigated. Study aims will evaluate: 1) the performance of the FES PET/MRI in axillary staging compared with axillary surgery; 2) potential correlations between changes in FES uptake and changes in proliferation index after three weeks of endocrine therapy (ET); 3) the performance of the FES PET/MRI in systemic staging of patients undergoing systemic therapy in comparison with standard imaging; 4) biological determinants of tumor heterogeneity on pathological, imaging, and genomic levels. Statistics: The primary analysis in cohort A will test the sensitivity of the FES PET/MRI in detecting macrometastatic axillary nodes. Assuming that the probability that a patient has positive nodes is 33%, 119 patients (10% drop-out included) will provide 80% power to reject the null hypothesis about sensitivity at a 5% significance level if the true sensitivity is at least 50%. Results from the FES PET/MRI will be also compared with standard imaging in terms of sensitivity and number of lesions detected using the Mc-Nemar test for paired proportions and the Wilcoxon signed-rank test for paired data. The primary analysis in Cohort B will test the association between the FES-SUV change from pre-ET to post-ET and the Ki-67 change from core biopsy to post-ET in ER positive BC patients with a Ki-67 >10%. The association between these changes will be measured by the Pearson correlation index ρ. Α total of 52 patients (10% drop-out included) from Cohort B will provide 80% power to reject the null hypothesis about ρ at a 5% significance level if the true ρ is at least 0.4. No formal sample size was calculated for cohort C and D: results will be considered descriptive in nature, informing sample size considerations for future trials. We intent to recruit 20 and 30 patients, respectively. Accrual has not started yet. Project funded by AIRC (Associazione Italiana Ricerca sul Cancro) Next Gen Clinician Scientist ID 28378 Contact: Dr. Rosa Di Micco, dimicco.rosa@hsr.it Citation Format: Rosa Di Micco, Carla Canevari, Francesca Gallivanone, Nicole Rotmensz, Veronica Zuber, Sara Baleri, Giovanni Cisternino, Mario Rampa, Stefania Zambelli, Giulia Viale, Patrizia Zucchinelli, Manuela Morgante, Paola Scifo, Elena Venturini, Paola Magnani, Isabella Sassi, Vincenzo Bagnardi, Pietro Panizza, Giampaolo Bianchini, Arturo Chiti, Oreste Davide Gentilini. FES-PET/MRI for Tailored treatment of luminal A and lobular breast cancer: a prospective cohort study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-19-03.

A Primer on Genetic Testing for Horse Owners and Breeders

With the increasing development of genetic testing and advanced genomic technologies, horse owners and breeders have more opportunities than ever before to learn more about the genetic background of their horses. This publication provides information to help horse owners and breeders understand what genetic testing services are, which genetic tests are available for their horses, and how to locate genetic testing services. Written by Julia L. Ciosek, Carissa Wickens, and Samantha A. Brooks, and published by the Veterinary Medicine—Department of Large Animal Clinical Sciences, UF/IFAS Extension, April 2024.

Career trajectories of MD-PhD physician scientists: The loss of women investigators

Advances in biomedical research require a robust physician scientist workforce. Despite being equally successful at securing early career awards from the NIH as men, women MD-PhD physician scientists are less likely to serve as principal investigators on mid- and later careers awards. Here, Steinman etal. discuss the causes of gender disparities in academic medicine, the implications of losing highly trained women physician scientists, and the institutional and systemic changes needed to sustain this pool of talented investigators.

Influence of the Tissue Collection Procedure on the Adipogenic Differentiation of Human Stem Cells: Ischemic versus Well-Vascularized Adipose Tissue

Clinical and basic science applications using adipose-derived stem cells (ADSCs) are gaining popularity. The current adipose tissue harvesting procedures introduce nonphysiological conditions, which may affect the overall performance of the isolated ADSCs. In this study, we elucidate the differences between ADSCs isolated from adipose tissues harvested within the first 5 min of the initial surgical incision (well-vascularized, nonpremedicated condition) versus those isolated from adipose tissues subjected to medications and deprived of blood supply during elective free flap procedures (ischemic condition). ADSCs isolated from well-vascularized and ischemic tissues positively immunostained for several standard stem cell markers. Interestingly, the percent change in the CD36 expression for ADSCs isolated from ischemic versus well-vascularized tissue was significantly lower in males than females (p < 0.05). Upon differentiation and maturation to adipocytes, spheroids formed using ADSCs isolated from ischemic adipose tissue had lower triglyceride content compared to those formed using ADSCs isolated from the well-vascularized tissue (p < 0.05). These results indicate that ADSCs isolated from ischemic tissue either fail to uptake fatty acids or fail to efficiently convert those fatty acids into triglycerides. Therefore, more robust ADSCs suitable to establish in vitro adipose tissue models can be obtained by harvesting well-vascularized and nonpremedicated adipose tissues.

Ex Vivo Drug Evaluation Using Human Ocular Cells: A Contribution to Drug Discovery

The field of therapeutics is fundamentally and heavily dependent on drug discovery. The record number of new agents being developed probably conceals how ardent the task is [1]. Drug discovery is indeed a long, costly, and high-risk process that takes over 10-15 years with an average cost of over $1-2 billion for a new drug to be approved for clinical use [2]. What is astonishing is the failure rate of candidate drugs. By most accounts over 90% of drug candidates fail to be approved for clinical use. Lack of clinical efficacy and poor drug-like properties along with unmanageable toxicity are among the frequent reasons for their failure. The transition between basic and clinical science, known colloquially and the “valley of death”, is where most promising discoveries meet their demise [3]. Multiple efforts have been made to overcome this difficult situation that adversely affects modern therapeutics [2].

Knowledge, Attitudes, and Behaviors of Medical Residents towards Traditional and Complementary Medicine: A Cross-sectional Study

Objective: This study aimed to evaluate the knowledge, attitudes, and behaviors of medical residents working at a faculty of medicine hospital about Traditional and Complementary Medicine (TCM). Material-Method: This is a cross-sectional study. The study was conducted with clinical science assistants working at the faculty of medicine between 15 July and 15 December 2021. A survey containing questions to determine the clinical and demographic characteristics of the participants and their knowledge, behavior, and attitudes toward TCM applications was applied to the participants. Results: A total of 261 medical residents participated. The average age was 29.4±2.6 years and 51.7% (n=135) were male. 82% of the participants were studying internal medicine sciences. The average length of time as a physician was found to be 4.4 years, and the average length of time as a physician in the total branch was 2.6 years. Cupping therapy was the most known method with 55.6%. The most frequently used method (19.2%) was phytotherapy; the most frequently recommended (16.5%) was phytotherapy; the most formally trained (4.2%), was cupping therapy; the most desired formal training (41%) was acupuncture; the most frequently declared method (11.9%) as another TCM method was diet. 36.4% of the participants found TCM useful. 82% thought that these methods should only be applied by trained physicians. Conclusion: It was determined that the level of TCM knowledge among assistant physicians was low. Although the majority of participants had a positive attitude towards TCM, they had low rates of application, implementation, and recommendation.

Arrhythmia detection by the graph convolution network and a proposed structure for communication between cardiac leads

One of the most common causes of death worldwide is heart disease, including arrhythmia. Today, sciences such as artificial intelligence and medical statistics are looking for methods and models for correct and automatic diagnosis of cardiac arrhythmia. In pursuit of increasing the accuracy of automated methods, many studies have been conducted. However, in none of the previous articles, the relationship and structure between the heart leads have not been included in the model. It seems that the structure of ECG data can help develop the accuracy of arrhythmia detection. Therefore, in this study, a new structure of Electrocardiogram (ECG) data was introduced, and the Graph Convolution Network (GCN), which has the possibility of learning the structure, was used to develop the accuracy of cardiac arrhythmia diagnosis. Considering the relationship between the heart leads and clusters based on different ECG poles, a new structure was introduced. In this structure, the Mutual Information(MI) index was used to evaluate the relationship between the leads, and weight was given based on the poles of the leads. Weighted Mutual Information (WMI) matrices (new structure) were formed by R software. Finally, the 15-layer GCN network was adjusted by this structure and the arrhythmia of people was detected and classified by it. To evaluate the performance of the proposed new network, sensitivity, precision, specificity, accuracy, and confusion matrix indices were used. Also, the accuracy of GCN networks was compared by three different structures, including WMI, MI, and Identity. Chapman’s 12-lead ECG Dataset was used in this study. The results showed that the values of sensitivity, precision, specificity, and accuracy of the GCN-WMI network with 15 intermediate layers were equal to 98.74%, 99.08%, 99.97% & 99.82%, respectively. This new proposed network was more accurate than the Graph Convolution Network-Mutual Information (GCN-MI) with an accuracy equal to 99.71% and GCN-Id with an accuracy equal to 92.68%. Therefore, utilizing this network, the types of arrhythmia were recognized and classified. Also, the new network proposed by the Graph Convolution Network-Weighted Mutual Information (GCN-WMI) was more accurate than those conducted in other studies on the same data set (Chapman). Based on the obtained results, the structure proposed in this study increased the accuracy of cardiac arrhythmia diagnosis and classification on the Chapman data set. Achieving such accuracy for arrhythmia diagnosis is a great achievement in clinical sciences.

Systemic Sclerosis-Associated Pulmonary Arterial Hypertension: From Bedside to Bench and Back Again.

Systemic sclerosis (SSc) is a heterogeneous disease characterized by autoimmunity, vasculopathy, and fibrosis which affects the skin and internal organs. One key aspect of SSc vasculopathy is pulmonary arterial hypertension (SSc-PAH) which represents a leading cause of morbidity and mortality in patients with SSc. The pathogenesis of pulmonary hypertension is complex, with multiple vascular cell types, inflammation, and intracellular signaling pathways contributing to vascular pathology and remodeling. In this review, we focus on shared molecular features of pulmonary hypertension and those which make SSc-PAH a unique entity. We highlight advances in the understanding of the clinical and translational science pertinent to this disease. We first review clinical presentations and phenotypes, pathology, and novel biomarkers, and then highlight relevant animal models, key cellular and molecular pathways in pathogenesis, and explore emerging treatment strategies in SSc-PAH.

Psychological clinical science: Meeting the challenge of public mental health

The purpose of this article is to provide a brief overview of how clinical psychology evolved in the United States as a prelude to discussing the emergence of psychological clinical science in the closing years of the 20th century. Despite the growth of clinical psychology, mental disorders remain highly prevalent, compelling us to envision new ways to deliver services in an effective but efficient manner. Topics include the dissemination gap, the affordable access gap, and the Psychological Clinical Science Accreditation System (PCSAS). Examples of novel methods for addressing the problem of public mental health in the 21st century are discussed. Finally, I close by considering the potential relevance of our experience in America for European clinical psychology.

Fertility 2024 Rethinking Reproduction 10th–13th January 2024, Edinburgh The joint conference of the Association of Reproductive & Clinical Scientists, British Fertility Society, and the Society for Reproduction & Fertility

Fertility 2024 Rethinking Reproduction 10th–13th January 2024, Edinburgh The joint conference of the Association of Reproductive & Clinical Scientists, British Fertility Society, and the Society for Reproduction & Fertility

Human Milk Oligosaccharides: Potential Upshot on Health at Early Life Stage Development

In the crucial early months of life, an infant's health, growth, and safeguarding are paramount. Breastfeeding stands out as the optimal and natural means of nourishment, offering profound benefits for their development and overall wellness. Within breast milk, a rich array of bioactive components, including hormones, oligosaccharides, and immunoglobulins, provide neonates with an ideal nutritional balance. Among these, Human Milk Oligosaccharides (HMOs) rank prominently, serving both as prebiotics and shields against various neonatal ailments. Particularly, compounds like 2′-Fucosyllactose (2′-FL) and Lacto-N-Neotetraose (LNnT) have been deemed safe for integration into infant formulas, amplifying their benefits. Extensive research underscores the manifold advantages of HMOs, from modulating gut microbiota to bolstering immune function and thwarting pathogenic invaders. HMOs also exhibit a nuanced interplay with maternal genetics, influencing their quantity and diversity. Infants nursed by secretor mothers tend to enjoy enhanced HMO benefits compared to non-secretor counterparts. Incorporating HMOs like Lacto-N-Neotetraose and 2′-Fucosyllactose into infant formulas represents a pivotal stride in optimizing child nutrition. This review offers a thorough exploration of recent research on HMOs, delving into their varied types, concentrations, and compositions, while emphasizing their profound impact on infant health and safety. By consolidating current research findings and recent progress, this study seeks to clarify the diverse effects of HMOs on different facets of human physiology, immune system maturation, modulation of gut microbiota, neurological functioning, and lifelong health implications. Emphasizing the pivotal role of HMOs in influencing human well-being from infancy to maturity, this review emphasize the necessity for continued research and potential utilization in clinical settings and nutritional science.

Current trends in retraction of plastic surgery and reconstruction research

Various studies regarding retractions of publications have determined the rate of retraction has increased in recent years. Although this trend may apply to any field, there is a paucity of literature exploring the publication of erroneous studies within plastic and reconstructive surgery. The present study aims to identify trends in frequency and reasons for retraction of plastic and reconstructive surgery studies, with analysis of subspecialty and journals. A database search was conducted for retracted papers within plastic and reconstructive surgery. The initial search yielded 2347 results, which were analyzed by two independent reviewers. 77 studies were jointly identified for data collection. The most common reasons for retractions were duplication (n=20, 25.9%), request of author (n=15, 19.5%), plagiarism (n=9, 11.6%), error (n=9, 11.6%), fraud (n=2, 2.6%), and conflict of interest (n=1, 1.3%). 15 were basic science studies (19.4%), 58 were clinical science studies (75.3%), and 4 were not categorized (5.2%). Subspecialties of retracted papers were maxillofacial (n=29, 37.7%), reconstructive (n=17, 22.0%), wound healing (n=8, 10.4%), burn (n=6, 7.8%), esthetics (n=5, 6.5%), breast (n=3, 3.9%), and trauma (n=1, 1.3%). Mean impact factor was 2.9 and average time from publication to retraction was 32 months. Analysis of retracted plastic surgery studies revealed a recent rise in frequency of retractions, spanning a wide spectrum of journals and subspecialties.

Altered transcriptomic immune responses of maintenance hemodialysis patients to the COVID-19 mRNA vaccine.

End-stage renal disease (ESRD) patients experience immune compromise characterized by complex alterations of both innate and adaptive immunity, and results in higher susceptibility to infection and lower response to vaccination. This immune compromise, coupled with greater risk of exposure to infectious disease at hemodialysis (HD) centers, underscores the need for examination of the immune response to the COVID-19 mRNA-based vaccines. The immune response to the COVID-19 BNT162b2 mRNA vaccine was assessed in 20 HD patients and cohort-matched controls. RNA sequencing of peripheral blood mononuclear cells was performed longitudinally before and after each vaccination dose for a total of six time points per subject. Anti-spike antibody levels were quantified prior to the first vaccination dose (V1D0) and 7 d after the second dose (V2D7) using anti-spike IgG titers and antibody neutralization assays. Anti-spike IgG titers were additionally quantified 6 mo after initial vaccination. Clinical history and lab values in HD patients were obtained to identify predictors of vaccination response. Transcriptomic analyses demonstrated differing time courses of immune responses, with prolonged myeloid cell activity in HD at 1 wk after the first vaccination dose. HD also demonstrated decreased metabolic activity and decreased antigen presentation compared to controls after the second vaccination dose. Anti-spike IgG titers and neutralizing function were substantially elevated in both controls and HD at V2D7, with a small but significant reduction in titers in HD groups (p<0.05). Anti-spike IgG remained elevated above baseline at 6 mo in both subject groups. Anti-spike IgG titers at V2D7 were highly predictive of 6-month titer levels. Transcriptomic biomarkers after the second vaccination dose and clinical biomarkers including ferritin levels were found to be predictive of antibody development. Overall, we demonstrate differing time courses of immune responses to the BTN162b2 mRNA COVID-19 vaccination in maintenance HD subjects comparable to healthy controls and identify transcriptomic and clinical predictors of anti-spike IgG titers in HD. Analyzing vaccination as an in vivo perturbation, our results warrant further characterization of the immune dysregulation of ESRD. F30HD102093, F30HL151182, T32HL144909, R01HL138628. This research has been funded by the University of Illinois at Chicago Center for Clinical and Translational Science (CCTS) award UL1TR002003.

P080 Supporting shared decision-making about osteoporosis medicines: Combining multiple methods to develop the prototype iFraP intervention

Abstract Background/Aims Shared decision-making (SDM) is a joint process in which a person and healthcare professional work together to reach decisions about care. The iFraP (Improving uptake of Fracture Prevention drug treatments) intervention comprises computerised decision aid (DA), Fracture Liaison Service (FLS) clinician training package, and information resources to support SDM about osteoporosis medicines. This abstract details our multi-method approach to develop this intervention. Methods Intervention development was underpinned by the Medical Research Council guidelines for development of complex interventions. Four studies guided intervention prototype development, including (1) an evidence synthesis of existing osteoporosis DAs to examine quality and effectiveness; (2) a review of patient information about osteoporosis to evaluate quality and optimal language for talking about osteoporosis; (3) a Delphi consensus survey with patients, carers, and health professionals to gain consensus on intervention content, informed by an evidence review of relevant clinical guidelines and behavioural theories; (4) and focus groups and interviews with patients recently attending FLS, FLS clinicians and general practitioners (GPs) to explore current FLS practice, and barriers and facilitators to change. Expert stakeholders and public contributors informed each sub-study. Results Studies one and two informed design of the iFraP computerised DA. Evidence reviews of existing osteoporosis DAs and patient information found that they did not meet patient needs and identified poor readability, variable quality, and unbalanced and confusing content. Public contributors preferred DAs which were individualised, and together with expert stakeholders, supported the development of understandable explanations of osteoporosis and osteoporosis medicines to include in iFraP resources. Study three identified essential components of the FLS consultation which directly informed DA content. Study four identified the need for complementary iFraP information resources, training, and potential barriers to iFraP DA use. Patients expressed that they did not feel adequately prepared for their FLS consultation, leading to the development of an enhanced leaflet to accompany their FLS appointment letter. Patients, FLS clinicians, and GPs all expressed the need for a patient-friendly individualised summary of the FLS consultation, to facilitate consistent information across services and reinforce FLS messaging. This finding informed development of the iFraP Bone Health Record, an individualised, easy-read PDF print-out of the iFraP DA. FLS clinicians identified training needs relating to communicating risk, involving patients in decisions and clinical decision-making. Barriers to use included concerns that the DA would increase consultation duration, and that SDM may undermine their goal to facilitate medicine adherence. Identified barriers to use and training needs informed the content and delivery of the interactive eLearning and role play session, with consideration of theoretically-informed behaviour change techniques. Conclusion The iFraP complex intervention development work demonstrates the use of multiple methods to develop an evidence-based and theoretically-driven intervention in-preparation for testing. Disclosure L. Bullock: None. J. Fleming: None. E.M. Clark: None. S. Leyland: None. S. Thomas: Grants/research support; ST owns Prescribing Decision Support Ltd that developed the iFraP decision aid. C. Gidlow: None. T.W. O'Neill: Grants/research support; TON is supported by the NIHR Manchester Biomedical Research Centre. C.P. Iglesias-Urrutia: None. A. Hawarden: Grants/research support; AH is funded by a Versus Arthritis Clinical Research Fellowship (reference 22726). F. Manning: None. J. Protheroe: None. J. Lefroy: None. S. Ryan: None. R. Horne: None. C.D. Mallen: Grants/research support; CM is funded by the NIHR Applied Research Collaboration West Midlands and the NIHR School for Primary Care Research. C. Jinks: Grants/research support; CJ is part funded by NIHR Applied Research Collaboration (ARC) West Midlands. Z. Paskins: Consultancies; ZP has received consultancy fees from UCB Pharma. Grants/research support; ZP is funded by the National Institute for Health Research (NIHR) [Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy].

P070 Rheum to Empower: Home Spirometry and Oximetry Monitoring in Connective Tissue Related Interstitial Lung Disease

Abstract Background/Aims Interstitial lung disease (ILD) is a common cause of morbidity and mortality in connective tissue diseases (CTDs). Distinct challenges arise for individuals with impairments from rheumatic diseases, especially when coupled with respiratory symptoms. While home spirometry monitoring is valuable for patients with idiopathic pulmonary fibrosis (IPF), its applicability in CTD related ILD (CTD-ILD) is relatively unexplored. This study examines the feasibility and acceptability of home spirometry and oximetry monitoring in CTD-ILD patients compared with those with IPF. Methods Patients with CTD-ILD and IPF were recruited prospectively in a tertiary hospital. A portable handheld spirometer (MIR Spirobank Smart) and a Nonin finger oximeter linked to a smartphone app were provided, and patients were educated on its use. Spirometry and oximetry results were collated. At six months, a survey was conducted to assess patients’ perception of home monitoring. Results Fourty-one patients with CTD-ILD and 51 with IPF were recruited. The median ages were 66 and 71 years respectively (Table 1). 2946 FVC and 2787 oximetry readings were captured in the CTD-ILD cohort compared with 4984 FVC and 4778 oximetry readings in the IPF cohort. Among the 41 patients, 12 experienced Raynaud’s phenomenon. Only 7.32% (3/41) of CTD-ILD patients required an ear oximeter due to inaccurate oxygen saturation measurement caused by Raynaud’s phenomenon. Among the CTD-ILD cohort, 16.67% (6/36) experienced difficulty using the devices due to hand problems, while none of the IPF cohort encountered such issues. In the survey, patients reported barriers to long-term remote monitoring usage included forgetting to use, coughing or breathlessness. Less than one-third of patients indicated that spirometry and oximetry results contributed to health anxiety. A majority of patients found home monitoring useful and insightful, and would recommend this to others. Conclusion Our findings suggest the practicality of remotely monitoring FVC and oximetry in CTD-ILD patients, even with challenges like Raynaud’s phenomenon and impaired hand function. This not only underscores feasibility but also empowers patients through continuous monitoring despite physical limitations. Incorporating remote monitoring into standard care should be regarded as an essential approach for this understudied population, enhancing both clinical management and patient empowerment. Disclosure W. Ng: Grants/research support; StAR MD Scholarship, ISR Rheumatology Patient Initiative Fund. D. Howard: None. L. Durcan: None. K. Hurley: Grants/research support; Health Research Board, Ireland, Emerging Clinical Scientist Award (ECSA-2020-011).

Viewpoint on the Benefit of Hearing Care on Cognitive Health.

The purpose of this article is to provide a viewpoint on the recently published results showing the positive effect hearing intervention can have on mitigating the risk of cognitive decline in elderly individuals with hearing impairment. We intend to trigger a broader discussion on the implications of these results from an implementation science perspective. Recently published results were reviewed and contextualized. In our view, these recent findings provide a great opportunity for hearing care professionals to change the perspective on hearing care being an essential service that contributes not only to managing challenges with audibility but to enabling healthy living and aging. As exciting as these findings are, from our perspective, they are also a call to action for the audiology field in terms of clinical implementation science. The findings guide us toward a more interprofessional approach in order to develop and test new, more holistic models of hearing care.

The journey from bench to bedside - it takes a science village.

I was fortunate enough to start my career at what was the dawn of modern-day molecular biology and to apply it to an important health problem. While my early work focused on fundamental science, the desire to understand human disease better and to find practical applications for research discoveries resulted, over the following decades, in creating a stream of translational research directed specifically towards epithelial cancers. This could only have been possible through multiple collaborations. This type of team science would eventually become a hallmark of my career. With the development of higher throughput molecular techniques, the pace of research and discovery have quickened, and the concept of personalized medicine based on genomics is now coming to fruition. I hope my legacy will not just reflect my published works, but will also include the impact I have had on the development of the next generation of scientist and clinician scientists who inspired me with their dedication, knowledge and enthusiasm.

Generalized anxiety disorder and selective attention: An unsuccessful replication of Yiend et al., (2015) in a student population

ABSTRACT Generalized Anxiety Disorder (GAD) is an anxiety disorder that is believed to affect attention (Stein, M. B., & Sareen, J. (2015). Generalized anxiety disorder. New England Journal of Medicine, 373(21), 2059–2068. https://doi.org/10.1056/NEJMcp1502514; Yiend, J., Mathews, A., Burns, T., Dutton, K., Fernández-Martín, A., Georgiou, G. A., Luckie, M., Rose, A., Russo, R., & Fox, E. (2015). Mechanisms of selective attention in generalized anxiety disorder. Clinical Psychological Science, 3(5), 758–771. https://doi.org/10.1177/2167702614545216). Previous literature has found that selective attention is changed when someone perceives threatening stimuli, such as an angry face, and that those with anxiety disorders, may have a heightened or delayed response to threatening stimuli (Richards, H. J., Benson, V., Donnelly, N., & Hadwin, J. A. (2014). Exploring the function of selective attention and hypervigilance for threat in anxiety. Clinical Psychology Review, 34(1), 1–13. https://doi.org/10.1016/j.cpr.2013.10.006; Stevens, C., & Bavelier, D. (2012). The role of selective attention on academic foundations: A cognitive neuroscience perspective. Developmental Cognitive Neuroscience, 2, S30–S48. https://doi.org/10.1016/j.dcn.2011.11.001), which may alter how fast a presented task is completed (Yiend et al., 2015). The present study aimed to reproduce findings by Yiend et al. (2015), which identified an unexpected pattern in those with GAD: faster disengagement from angry faces compared to positive (happy, neutral) faces. The present study recruited a larger (nonclinical) sample from a student population to achieve greater statistical power. None of the findings reported by Yiend and colleagues (Experiment 1; 2015) were replicated in a student sample. The implications are discussed.

Implementing a clinical scientist-led screening clinic for hypertrophic and dilated cardiomyopathies

BackgroundThe burden of screening for inherited cardiac conditions on health services grows ever larger, with each new diagnosis necessitating screening of additional family members. Screening these usually asymptomatic, low-risk individuals is currently performed by consultant cardiologists, consuming vital clinic resources that could otherwise be diverted to sicker patients requiring specialist consultant input. Clinical scientists now constitute a highly skilled and often underutilised group of individuals with training in areas such as clinical evaluation, 12-lead electrocardiography (ECG) interpretation, and echocardiography. These skills place them in a unique position to offer a full screening evaluation in a single consultation. The aim of this study was to implement and evaluate a novel clinical scientist-led screening clinic for first-degree relatives of patients with hypertrophic cardiomyopathy (HCM) and dilated cardiomyopathy (DCM). The clinical scientist-led screening clinic was established at a London tertiary centre to allow review of asymptomatic, first-degree relatives of patients with a confirmed diagnosis of HCM or DCM, independent of a cardiology consultant. Patients were evaluated with history, examination, ECG, and echocardiography, with further investigations if deemed necessary. A retrospective review was performed of the first 200 patients seen in the clinic.ResultsOf the 200 individuals reviewed between September 2019 and July 2022, 99 had a proband with HCM and 101 a proband with DCM. Overall, 169 individuals (85%) revealed normal screenings and were discharged. Thirty-one individuals (15.5%), all asymptomatic, revealed ECG changes and/or significant echocardiographic findings. Of these, 21 individuals (10.5% of the total cohort) were subsequently diagnosed with a cardiomyopathy or early phenotypic changes consistent with a cardiomyopathy (11 with HCM and 10 with DCM). These individuals were referred on to an inherited cardiac conditions consultant clinic for regular follow-up. Overall, 179 consultant clinic appointments were saved which could instead be allocated to patients requiring specialist consultant input.ConclusionsThis is the first description of a clinical scientist-led screening clinic for first-degree relatives of patients with HCM and DCM. The findings demonstrate that implementation of such a service into routine clinical practice is feasible, effective, safe, and can free up capacity in consultant clinics for patients requiring specialist input.