Clinical Research Training Research Articles

Recruitment Strategies To Improve Gender Equity in Clinical and Translational Research Training in Ethiopia.

Women from sub-Saharan Africa, including Ethiopia, are underrepresented in biomedical research due in part to limited access to high-quality research training and mentorship. Tuberculosis (TB) is a major public health problem in Ethiopia, with a limited number of female Ethiopian scientists engaged in TB-related research. To improve access to TB-related research training among junior women scientists, our NIH Fogarty International Center-funded D43 program released an all-women request for applications (RFA), which substantially increased the number of women applying for research training and the number of women trained in our program. The impact of the all-women cohort was also bolstered by prominent female representation in mentor teams, program leadership, and program alumnae. Sustained increases in applications from women were seen in subsequent RFAs that included both women and men. Targeted leadership, mentorship, and recruitment efforts were effective in promoting improved gender equity in biomedical research training.

Analysis about radiation risk perception among university students from San Carlos de Bariloche and radiological protection experts from Argentina

Radiation risk perception must be studied by communication and radiological protection specialists, taking account of engineering, social and cultural variables. An anonymous and voluntary survey was peformed to enquire about the radiation risk perception among university students and radiological protection experts from Argentina, and to become aware of how it is perceived compared to other health risks. A fifteen-question dedicated questionnaire was designed including socio-demographic variables and questions about work environment, risk perception and risk communication. A five-point Likert-type scale was used for most of the questions. Surveyed people were asked to compare radiological risks in medicine with other risks (i.e.: smoking, sports, leisure activities, stress). The research involved 10 (38.5%) experts, 25 (45%) physics and engineering students and 40 (100%) bio-images production bachelor students. The results were analysed based on the professional or academic background. Although participants considered the radiation exposure in medicine as a low-risk activity, the results showed a disagreement about the radiation risk perception in particular situations (i.e.: living near a nuclear power plant, training in radiological protection while at college) and about radiation risk communication strategies. There is neither right nor wrong risk perception; however, a lot of work must be done to build an agreement between radiological risk perception and risk assessment due to radiation exposure in medicine. It should include working on the design of public policies focused on radiological protection training for health staff and clinical research training for medical physicists and radiological protection specialists, while strengthening communication skills and channels.

Functional, patient-derived 3D tri-culture models of the uterine wall in a microfluidic array.

Can a functional in vitro model, containing the main cellular components of the uterine wall, be generated from cells derived from patient tissues? We present a three-dimensional (3D) physiologically relevant, organ-on-a-chip model of the uterine wall containing primary endometrial and myometrial cellular participants, generated from human uterine tissue. As a highly dynamic reproductive organ, the human uterus plays fundamental physiological roles in menstruation and childbirth. The endometrial-myometrial junction (EMJ) defines the interface between the inner mucosal layer (endometrium) and outer smooth muscle zone (myometrium) that comprises the uterine wall. The EMJ is implicit in several uterine pathologies of unknown aetiology, including adenomyosis and abnormally invasive placenta; however, despite this, no patient-derived in vitro models of the uterine wall containing all EMJ participants currently exist. We employed microfluidic technology to characterize multiple miniaturized models of the uterine wall. Protocols were tested that included variations in the seeding order of endometrial and myometrial fractions, and the addition of a low viscosity extracellular matrix to influence cell behaviour. Ultimately, functional hormone responses of patient-derived uterine wall models were assessed. Endometrial (n = 9) and myometrial biopsies (n = 4) were enzymatically dissociated to create epithelial, stromal and myometrial cellular fractions. Cell suspensions were seeded into non-adhesive poly(dimethylsiloxane) microfluidic devices containing 5 × 5 microwell arrays. The fate of individual cell types was monitored in real-time using fluorescent tracers, and cell phenotype was characterized by immunocytochemistry. Model functionality was assessed by measuring Ca2+ responses to agonist stimulation, and both insulin-like growth factor binding protein 1 (IGFBP-1) and osteopontin secretion in response to hormone stimulation. When subjected to microfluidic culture in isolation, endometrial stromal cells and smooth muscle myocytes formed compact spheroids, whilst epithelial cells produced diffuse aggregates. Tri-cultures were established by sequential seeding of individual or combined cell fractions at various ratios. Regardless of the protocol, epithelial cells localized to the outer periphery of tri-culture spheroids, which varied in morphology across the protocols. Incorporation of 5% [v/v] Matrigel® improved the reproducibility of 3D aggregates which exhibited robust self-assembly of a stromal/smooth muscle core encased in epithelium. Exposure of tri-cultures to oestradiol, medroxyprogesterone acetate and cyclic adenosine monophosphate (cAMP) increased secretion of IGFBP-1, which indicates stromal decidualization, and enhanced epithelial cell osteopontin secretion. Stimulation with endothelin-1 induced Ca2+ signalling in myocytes. Endometrial and myometrial tissue was collected from relatively few donors. Myometrial tissue was collected from pregnant donors, which may have influenced the myocyte phenotype. Furthermore, endometrial tissue sampling was from women not having a hysterectomy, thus may not include the deeper basalis region, which may limit the physiological mimicry of the final models. Our novel approach to modelling the uterine wall in 3D captures all of the main cell types in a medium-throughput system, enabling the screening of hundreds of cultures in parallel from a single biopsy. This system shows great promise for examining the cellular interplay between physiological cues and EMJ pathologies, such as the impact of uterine peristalsis and cyclical hormones on the pathogenesis of adenomyosis. C.B. was supported by an Organ-on-a-Chip Technologies Network Pump Priming Project grant. C.J.H. was supported by a Wellbeing of Women project grant (RG2137), SRI/Bayer and Wellcome Trust IFFS3. D.K.H. was supported by a Wellbeing of Women project grant (RG2137) and MRC clinical research training fellowship (MR/V007238/1). M.Z. is Director and Co-Founder of ScreenIn3D Limited. The other authors declare no conflict of interest. N/A.

Educating hematology-oncology fellows about how to communicate with patients about cancer clinical trials: A needs assessment.

9029 Background: Cancer clinical trials (CCTs) are vital to advancing treatment yet only 5-8% of people with cancer ever participate, with even lower rates among underserved groups. Teaching oncologists in training how to communicate about CCTs may improve the frequency and quality of patient-oncologist communication about CCTs and increase participation. However, little is known about interest in or feasibility of such training during Hematology-Oncology (Hem-Onc) graduate medical education (GME) fellowships. We aimed to determine Hem-Onc fellowship programs’: 1) current practices, needs, and preferences for CCT-related communication training; and 2) the acceptability and feasibility of implementing a CCT communication skills workshop. Methods: We recruited and surveyed program directors (PDs) from Hem-Onc fellowship programs across the U.S. PDs were recruited via email through the ASCO program directors’ community, a publicly accessible list of ACGME Hematology-Oncology programs, and co-authors’ professional networks. Participants were compensated with a $50 gift card. Survey data were analyzed using descriptive statistics and responses were measured on a 5-point Likert scale (1 = “strongly disagree” to 5 = “strongly agree”). Results: 40 PDs were surveyed, most representing programs in the Northeast (30%), Midwest (25.6%), Southeast (20.5), and Southwest (15.4%) U.S. Most were male (57%) and identified as White (55%), Asian (30%), Black/African American (2.5%) and Native American/Alaskan Native (2.5%). PDs stated their institutions prioritize CCT accrual (M=4.58, SD=.78) and clinical research training (M=4.20, SD=.85). They reported their GME CCT curriculum least often addressed: (1) How to talk to patients about CCTs when none are available (27.5%), and (2) How to help patients find CCTs at other institutions (17.5%). PDs rated their fellows’ CCT knowledge as lowest in: (1) Provider-level barriers to enrolling/referring patients in CCTs (M=3.41, SD=.91) and (2) System-level barriers to patient accrual to CCTs (M=3.33, SD=.95). Fellows’ lowest-rated CCT communication skills areas were: (1) Making shared decisions with patients about CCT participation (M=3.54, SD=1.14) and (2) Patient-centered communication (M=3.50, SD=1.15). PDs were interested in a CCT communication workshop (‘yes’=67.5%, ‘maybe’=32.5%) and said such training was feasible (M=4.28, SD=.78) and useful (M=4.47, SD=.78). Training preferences were live presentations (M=3.9, SD=1.03) and program-tailored virtual workshops (M=3.9, SD=1.08). Conclusions: Hem-Onc fellowship program leaders expressed a need for training that improves fellows’ CCT knowledge and patient-centered communication skills. By highlighting current practices, challenges, and preferences, this study is an important step towards implementing and scaling communication skills training in GME programs.

Endometrial compaction to predict pregnancy outcomes in patients undergoing assisted reproductive technologies: a systematic review and meta-analysis.

Does endometrial compaction (EC) help predict pregnancy outcomes in those undergoing ART? EC is associated with a significantly higher clinical pregnancy rate (CPR) and ongoing pregnancy rate (OPR), but this does not translate to live birth rate (LBR). EC describes the progesterone-induced decrease in endometrial thickness, which may be observed following the end of the proliferative phase, prior to embryo transfer. EC is proposed as a non-invasive tool to help predict pregnancy outcome in those undergoing ART, however, published data is conflicting. A literature search was carried out by two independent authors using PubMed, Cochrane Library, MEDLINE, Embase, Science Direct, Scopus, and Web of Science from inception of databases to May 2023. All peer-reviewed studies reporting EC and pregnancy outcomes in patients undergoing IVF/ICSI treatment were included. The primary outcome is LBR. Secondary outcomes included other pregnancy metrics (positive pregnancy test (PPT), CPR, OPR, miscarriage rate (MR)) and rate of EC. Comparative meta-analyses comparing EC and no EC were conducted for each outcome using a random-effects model if I 2 > 50%. The Mantel-Haenszel method was applied for pooling dichotomous data. Results are presented as odds ratios (OR) with 95% CI. Out of 4030 screened articles, 21 cohort studies were included in the final analysis (n = 27 857). No significant difference was found between LBR in the EC versus the no EC group (OR 0.95; 95% CI 0.87-1.04). OPR was significantly higher within the EC group (OR 1.61; 95% CI 1.09-2.38), particularly when EC ≥ 15% compared to no EC (OR 3.52; 95% CI 2.36-5.23). CPR was inconsistently defined across the studies, affecting the findings. When defined as a viable intrauterine pregnancy <12 weeks, the EC group had significantly higher CPR than no EC (OR 1.83; 95% CI 1.15-2.92). No significant differences were found between EC and no EC for PPT (OR 1.54; 95% CI 0.97-2.45) or MR (OR 1.06; 95% CI 0.92-1.56). The pooled weighted incidence of EC across all studies was 32% (95% CI 26-38%). Heterogeneity due to differences between reported pregnancy outcomes, definition of EC, method of ultrasound, and cycle protocol may account for the lack of translation between CPR/OPR and LBR findings; thus, all pooled data should be viewed with an element of caution. In this dataset, the significantly higher CPR/OPR with EC does not translate to LBR. Although stratification of women according to EC cannot currently be recommended in clinical practice, a large and well-designed clinical trial to rigorously assess EC as a non-invasive predictor of a successful pregnancy is warranted. We urge for consistent outcome reporting to be mandated for ART trials so that data can be pooled, compared, and concluded on. H.A. was supported by the Hewitt Fertility Centre. S.G.P. and J.W. were supported by the Liverpool University Hospital NHS Foundation Trust. D.K.H. was supported by a Wellbeing of Women project grant (RG2137) and MRC clinical research training fellowship (MR/V007238/1). N.T. was supported by the National Institute for Health and Care Research. D.K.H. had received honoraria for consultancy for Theramex and has received payment for presentations from Theramex and Gideon Richter. The remaining authors have no conflicts of interest to report. PROSPERO CRD42022378464.

Effectiveness of simulation-based clinical research curriculum for undergraduate medical students - a pre-post intervention study with external control

BackgroundSimulation is widely utilized in medical education. Exploring the effectiveness of high-fidelity simulation of clinical research within medical education may inform its integration into clinical research training curricula, finally cultivating physician-scientist development.MethodsStandard teaching scripts for both clinical trial and cross-sectional study simulation were designed. We recruited undergraduates majoring in clinical medicine at 3th grade into a pre-post intervention study. Additionally, a cross-sectional survey randomly selected medical undergraduates at 4th or 5th grade, medical students in master and doctor degree as external controls. Self-assessment scores of knowledge and practice were collected using a 5-point Likert scale. Changes in scores were tested by Wilcoxon signed-rank test and group comparisons were conducted by Dunn’s tests with multiple corrections. Multivariable quantile regressions were used to explore factors influencing the changes from baseline.ResultsSeventy-eight undergraduates involved the clinical trial simulation and reported improvement of 1.60 (95% CI, 1.48, 1.80, P < 0.001) in knowledge and 1.82 (95% CI, 1.64, 2.00, P < 0.001) in practice score. 83 undergraduates involved in the observational study simulation and reported improvement of 0.96 (95% CI, 0.79, 1.18, P < 0.001) in knowledge and 1.00 (95% CI, 0.79, 1.21, P < 0.001) in practice. All post-intervention scores were significantly higher than those of the three external control groups, P < 0.001. Higher agreement on the importance of clinical research were correlated with greater improvements in scores. Undergraduates in pre-post study showed high confidence in doing a future clinical research.ConclusionOur study provides evidence supporting the integration of simulation into clinical research curriculum for medical students. The importance of clinical research can be emphasized during training to enhance learning effect.

Opinion & Special Article: Community Approach Toward Inclusion of Sex and Gender Diversity in Graduate Neurology Education.

Sex and gender diverse (SGD) neurology trainees include transgender, nonbinary, and intersex people. There has been historical exclusion of SGD trainees from participating in clinical care, medical research, and academic training programs. Therefore, neurology educators have unique opportunities to support SGD trainees and colleagues, but may lack the education to appropriately do so. Training programs and professional organizations can collaborate to create safe pathways for SGD trainees to disclose their identities in professional settings. Referral to community support and resources is important for SGD trainees considering professional disclosure. Educators should address the challenges and discrimination unique to SGD graduate trainees in neurology, such as lack of inclusion, affirming environments, supportive policies, and medical accommodations. Faculty training on sensitivity, bias, and bystander effects should be ongoing among institutions. Topics regarding sex and gender diversity are lacking in graduate medical education. Educational curricula often use outdated terminology or binary paradigms to teach about sex and gender. Health care training inequities may cause downstream harm to SGD patients; therefore, training curricula that are reflective of an accurate and affirming understanding of sex and gender may mitigate the potential for inequities. This article provides recommendations to support SGD neurology trainees and to incorporate specific training on sex and gender diversity in academic neurology curricula. Such support is critical to the career success and development of SGD neurology trainees.

120 Impact of Undergraduate Clinical Research Experience: Highlighting the UCLA Clinical and Translational Science Institute Research Associates Program (CTSI-RAP)

OBJECTIVES/GOALS: CTSI-RAP is a professional development program that provides undergraduate students with clinical research exposure and training. Students support UCLA research faculty by assisting with all aspects of the research process, including recruiting participants, data management, and presentations. METHODS/STUDY POPULATION: CTSI-RAP onboards a 15-20 volunteer student cohort annually in a competitive application and interview process with less than a 10% acceptance rate. Since the inaugural cohort in 2013, over 160 students have participated. The program engages hundreds of students each year through the recruitment process, campus clinical research events, and student-led conference opportunities. Evaluation surveys developed through REDCap in 2022 sought to assess the program’s impact on undergraduate experiences, professional development, and post-graduate careers. Surveys distributed to investigators and their study teams evaluated the student’s clinical research knowledge and engaged student involvement. RESULTS/ANTICIPATED RESULTS: Based on evaluation surveys, the CTSI-RAP program received excellent reviews from both students and their assigned study teams. 100% of students and faculty would recommend the program to a friend or colleague. 30% of students present or publish annually, indicating a wealth of meaningful contributions made by students. 90% of students go on to attend medical school, health-related graduate school, or other health-related employment. Several students continue working in clinical research through gap-year employment. As demonstrated by the high caliber of student and faculty experiences, CTSI-RAP has created an esteemed and valued symbiotic infrastructure to support clinical research endeavors at UCLA. DISCUSSION/SIGNIFICANCE: Through clinical research career exploration and professional skill-building in undergraduate careers, the CTSI-RAP program produces highly-trained future leaders in the field and benefits the capacity of UCLA research. CTSI-RAP provides a model for similar programs to be funded and implemented in other institutions.

The Design and Early Results of a Structured Longitudinal Training Program for Undergraduate Students to Increase Diversity in Aging-Research.

Background: The Cultivating Health and Aging Researchers by Integrating Science, Medicine, and Aging (CHARISMA) program at the University of Chicago (UC), is an NIA-funded longitudinal clinical research training program for undergraduate students from groups underrepresented in the sciences and medicine. CHARISMA students participate in an aging-focused: 1) realistic research career experience, 2) didactic curriculum, and 3) multi-tiered mentorship program. This manuscript describes CHARISMA and early quantitative data demonstrating its success. Methods: Students apply for and are accepted into CHARISMA in year-long intervals, with programming lasting from June to May. Short-term outcomes are measured using student surveys, including an adapted 23-question version of the critical research appraisal inventory (CRAI), the Geriatrics Attitude Scale for Primary Care Residents, and questions rating the overall program, mentor, importance of aging research, and career interests. Results: Twenty-two students have completed CHARISMA. After completing CHARISMA, student aggregate CRAI scores increased (6.8 to 7.5, p = 0.04). Additionally, the substantial majority of students completing CHARISMA were definitely, very or somewhat Additionally, 87% (19/22), 73% (16/22), and 82% (18/22) of students were definitely, very, or somewhat interested in pursuing a career in medicine that serves older adults, pursuing a career in clinical research, or pursuing a career focused on aging-related research. Conclusion: Early data demonstrates that CHARISMA increases undergraduate student knowledge of and interest in aging-related clinical research.

Supporting clinical research professionals through educational innovations.

Clinical Research Professionals (CRPs) are essential members of the Clinical and Translational Research Workforce. Many academic medical institutions struggle to recruit and retain these vital team members. One strategy to increase job satisfaction and promote the retention of CRPs is through educational initiatives that provide training and professional development. The South Carolina Clinical and Translational Research (SCTR) Institute Workforce Development (WD) team at the Medical University of South Carolina (MUSC) developed several trainings as part of our larger educational portfolio for CRPs. In 2022 WD implemented a digital badge micro-credential for SCTR's Core Clinical Research Training (CCRT) course in collaboration with institution-wide education and technology offices. Beginning in January 2023, individuals were able to earn the CCRT Certified Digital Badge upon successful completion of the CCRT course.

Educating Hematology-Oncology Fellows About How to Communicate with Patients About Clinical Trials: A Needs Assessment.

Only 5-8% of adults with cancer participate in cancer clinical trials (CCTs), with even lower rates among underrepresented groups. Improving oncologists' communication skills may enhance the frequency and quality of their discussions with patients about CCTs, consequently increasing participation. However, little is known about interest in or presence of CCT-related communication training during Hematology-Oncology (Hem-Onc) fellowships. This study aimed to describe, from the perspective of Hem-Onc fellowship program directors (PDs): (1) the current landscape of CCT education for Hem-Onc fellows; (2) the acceptability and feasibility of implementing a CCT communication skills workshop for Hem-Onc fellows. We used an explanatory sequential mixed-methods approach. PDs were surveyed and interviewed about their graduate medical education (GME) programs' current CCT curriculum, training challenges, fellows' CCT knowledge and CCT communication skills, and preferences for a CCT communication workshop. PDs were surveyed (n = 40) and interviewed (n = 12). PDs reported that their institutions prioritize CCT accrual (M = 4.58, SD = .78; 1-5 scale, 5 = "Strongly Agree") and clinical research training (M = 4.20, SD = .85). CCT skills that programs least often addressed were how to (1) discuss CCTs with newly diagnosed patients, (2) talk to patients about CCTs when none are available, and (3) help patients find CCTs at other institutions. PDs were interested in a CCT communication workshop for fellows ("yes" = 67.5%, "maybe" = 32.5%) and said training would be feasible (M = 4.28, SD = .78) and useful (M = 4.47, SD = .78). Qualitative results described programs' current approaches to CCT education and insights about developing and implementing CCT communication training. There is a clear need to improve CCT communication skills training in Hem-Onc fellowship programs and to implement and scale such training to increase CCT participation, especially among diverse patient populations. Furthermore, Hem-Onc GME PDs view such training as feasible and useful.

Assessment of the Need for Training in Clinical Pharmacology Research on Traditional Medicine among Modern Medicine Practitioners: A Questionnaire-based Study

Introduction: Training young doctors is essential for carrying out need-based research. The field of Traditional Medicine (TM) has made significant contributions to modern medicine, and there is unlimited scope for exploring it further in search of improved treatment options. However, there is a lack of systematic research studies on traditional medicines. It was, therefore, considered necessary to assess the interest and awareness among modern medicine practitioners regarding Traditional Medicine Research (TMR). Aim: To assess the need for training in TMR among modern medicine practitioners. Materials and Methods: A cross-sectional questionnaire-based study was conducted in the Department of Pharmacology and Therapeutics at Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India, from March 2020 to September 2020 among modern medicine practitioners from the Western region of India. A validated questionnaire was used to collect data regarding the level of training in research methodology, research experience including TMR, areas for training, attitude towards training in TMR, challenges in TMR, and therapeutic areas to focus TMR efforts. The data were analysed using descriptive statistics. Results: Out of 109 participants, 96 (88.1%) were trained in research methodology. At least one research project was undertaken by 91 (83.5%) participants. Ninety-seven percent of participants felt that TMR was necessary. TMR was conducted by 19 (17.4%) participants. Approximately 65 (59.6%) participants felt that conducting TMR poses challenges such as lack of funds, infrastructure, lack of belief in TM, unavailability of literature pertaining to TM, lack of expertise, and lack of corporate attention and marketing. Therapeutic areas identified to focus research efforts included lifestyle-related disorders, diabetes mellitus, cancer, ageing, allergic disorders, osteoarthritis, and obesity. Conclusion: All the participants expressed the need to undergo training in TMR. However, the experience of conducting TMR was limited. Lack of funds, infrastructure, and expertise were mentioned as the main hurdles in undertaking TMR. It is essential to conduct systematic and need-based training programs for modern medicine practitioners in basic research methodology and TMR.

To explore clinical pharmacists’ opinions, and their perceived barriers and facilitators, to supporting clinical research delivery in secondary care

Abstract Introduction The National Health Service (NHS) is confronted with significant challenges in facilitating clinical research delivery.1 Clinical pharmacists were instrumental in ensuring patient safety while conducting urgent public health studies, such as the RECOVERY trial, during the COVID-19 pandemic.2 Numerous studies have reported the positive impact of pharmacy workforce in supporting clinical research delivery3. However, it remains unclear whether pharmacists are willing to take on this extra responsibility. Aim To explore the opinions of UK clinical pharmacists towards facilitating the delivery of clinical research in secondary care. Objectives include understanding the level of knowledge of clinical research among clinical pharmacists; assessing levels of interest among clinical pharmacists towards supporting clinical research delivery; identifying clinical pharmacists’ perceived barriers and facilitators to supporting clinical research delivery; and developing recommendations to facilitate pharmacists’ engagement in research delivery. Methods This study employed a qualitative research approach and utilised convenience sampling based on the researcher’s professional network. Eight pharmacists from two secondary care NHS Trusts participated. Individual semi-structured interviews were conducted using questions adapted from the Research Capacity and Culture (RCC) tool which was validated by two clinical trial pharmacists. Keele University Research Ethics Committee provided a favourable ethical opinion. Interview transcripts were analysed to identify emerging themes by using framework analysis. Results The findings revealed that participants possessed limited knowledge of clinical research in general. The key themes identified were categorised into three domains: individual, professional, and organisational, which corresponded with the RCC tool. In the individual domain, pharmacists demonstrated interest in clinical research delivery but lacked confidence. They acknowledged clinical research as contributing to evidence-based practice and enhancing professional development. However, they expressed concerns about patient harm resulting from trial interventions and poorly designed studies generating misleading data. Within the professional domain, pharmacists' capability to support clinical research delivery was limited by inadequate training in clinical research, their clinical skills, and their disease knowledge. They perceived internal and external barriers to participation. It has been suggested to improve the research culture within the profession and promote the role pharmacists can play in delivering research among other healthcare professionals. In the organisational domain, the workplace environment was perceived to present obstacles due to competing priorities and clinical research not being seen to be a core duty by managers. Additionally, awareness of clinical research opportunities was limited and exposure to clinical research-related activities within the workplace was minimal. Discussion/Conclusion Recommendations to address these barriers include promoting clinical research training, developing mentorship programs, creating platforms to connect clinical pharmacists with research opportunities, and identifying roles that allow pharmacists to incorporate clinical research into their routine practice. This research project has several limitations, including the use of a convenience sampling method, a small sample size and potential interviewer bias due to research participants all being known to the researcher. In summary, the pharmacy workforce possesses the potential to support the challenges in clinical research delivery faced by the NHS. However, addressing the perceived barriers is critical to enhancing pharmacist involvement in this field.

Impact of COVID-19 pandemic on surgical residency: Residents' perception

BACKGROUND: World Health Organization declared COVID-19 outbreak a pandemic, and till the month of March 2023, globally, there have been 761,402,282 confirmed cases of COVID-19, including 6887,000 deaths. In India, almost 44,707,525 cases been recorded till date. Here, almost 30,000,000 cases been recorded after the second wave. The working force fighting this pandemic is majority formed by resident doctors all over the country and globally. MATERIALS AND METHODS: This study was conducted among 110 residents pursuing postgraduation in surgery and allied departments in various training institutions in Tamil Nadu for a duration of 6 months (after the second wave). A pretested and validated questionnaire was formulated to assess the effect of COVID-19 pandemic on surgical trainee's residency program from their perspective. The questionnaire contained basic social-demographic details and general information like the details of surgical specialty they are admitted to, the overall details of changes in their surgical residency experience in the times of COVID pandemic and the changes faced by them in their day-to-day clinical, diagnostic, and surgical learning. The questionnaire also investigated the redeployment status of the surgical trainees to COVID treatment units and their perspective on the changes in their clinical research and surgical skills training. RESULTS: The study participants, 66%, were aged between 25 and 30 years, followed by 30 and 35 years (25.5%). Almost 80% of the participants belong to the final year of postgraduation; 67.3% of surgical trainees strongly perceives and all 100% of them accept the fact that their surgical residency has been affected by the ongoing pandemic. Fifty percent of the trainees were redeployed to COVID duties for 8 h a day shift and rest attended a minimum of 4 h of COVID duties. More than 75% of the residents had COVID duties of 5–10 h/day and more than 90% of these redeployed trainees involved in COVID duties have expressed that they had been suffering from extra stress and more than 60% were suffering from stress grade between 5 and 10 suggestive of high-stress level. Fifty-nine percent of the postgraduates in the current study mentioned that they require extra-surgical or skill-based training after their postgraduation period. CONCLUSION: The influence of COVID-19 on surgical trainees in various institutions of India has been immense due to overburdening of health systems by the large population of the country. Second wave of COVID, especially, has drastically changed the postgraduate surgical trainees' lives. Detrimental effects are not restricted to operative and clinical experience but also the mental health and well-being of them. The observations of the present study make recommendations for the future provision of training through skill-based surgical simulations so that the lost days of their trainings can be compensated and they become the confident surgeons of the future.

Consensus goals and standards for specialist cough clinics: the NEUROCOUGH international Delphi study.

Current guidelines on the management of chronic cough do not provide recommendations for the operation of specialist cough clinics. The objective of the present study was to develop expert consensus on goals and standard procedures for specialist cough clinics. We undertook a modified Delphi process, whereby initial statements proposed by experts were categorised and presented back to panellists over two ranking rounds using an 11-point Likert scale to identify consensus. An international panel of 57 experts from 19 countries participated, with consensus reached on 15 out of 16 statements, covering the aims, roles and standard procedures of specialist cough clinics. Panellists agreed that specialist cough clinics offer optimal care for patients with chronic cough. They also agreed that history taking should enquire as to cough triggers, cough severity rating scales should be routinely used, and a minimum of chest radiography, spirometry and measurements of type 2 inflammatory markers should be undertaken in newly referred patients. The importance of specialist cough clinics in promoting clinical research and cough specialty training was acknowledged. Variability in healthcare resources and clinical needs between geographical regions was noted. The Delphi exercise provides a platform and guidance for both established cough clinics and those in planning stages.

An Ode to the ASH Clinical Research Training Institute (CRTI) on Its 20th Anniversary

An Ode to the ASH Clinical Research Training Institute (CRTI) on Its 20th Anniversary

Modified Neuropixels probes for recording human neurophysiology in the operating room.

Neuropixels are silicon-based electrophysiology-recording probes with high channel count and recording-site density. These probes offer a turnkey platform for measuring neural activity with single-cell resolution and at a scale that is beyond the capabilities of current clinically approved devices. Our team demonstrated the first-in-human use of these probes during resection surgery for epilepsy or tumors and deep brain stimulation electrode placement in patients with Parkinson's disease. Here, we provide a better understanding of the capabilities and challenges of using Neuropixels as a research tool to study human neurophysiology, with the hope that this information may inform future efforts toward regulatory approval of Neuropixels probes as research devices. In perioperative procedures, the major concerns are the initial sterility of the device, maintaining a sterile field during surgery, having multiple referencing and grounding schemes available to de-noise recordings (if necessary), protecting the silicon probe from accidental contact before insertion and obtaining high-quality action potential and local field potential recordings. The research team ensures that the device is fully operational while coordinating with the surgical team to remove sources of electrical noise that could otherwise substantially affect the signals recorded by the sensitive hardware. Prior preparation using the equipment and training in human clinical research and working in operating rooms maximize effective communication within and between the teams, ensuring high recording quality and minimizing the time added to the surgery. The perioperative procedure requires ~4 h, and the entire protocol requires multiple weeks.

Integrated dual training in palliative care and oncology

Fellowship training in Hospice and Palliative Medicine (HPM) and Hematology/Oncology (Hem/Onc) share common themes and roots in the holistic care of people living with cancer. As of 2021, approximately 630 physicians in the United States were board-certified in both HPM and Hem/Onc. There is increasing demand for an integrated fellowship pathway, and the inaugural integrated fellowship Match took place in 2022. We present the historical context of the overlap in HPM and Hem/Onc fellowship training, limitations of the standard training paradigm, and an overview of the recently developed integrated training pathway accredited by the Accreditation Council for Graduate Medical Education (ACGME). We explore applications of dual training in clinical care, program development, and research at the intersection of HPM and Hem/Onc. Finally, we consider challenges to the success and how best to assess the outcomes of this program. Integrated fellowship training in HPM and Hem/Onc is 1 avenue to develop a cohort of dual-trained physicians poised to effect broad cultural change in this important and evolving space. A subset of physicians with dual training has the potential to fill unmet needs by promoting enhanced patient-centered care, developing infrastructure for heightened collaboration between these distinct but closely related fields, and prioritizing research focused on advanced communication skills and symptom management for patients with cancer.

Evidence for microstructural alteration and microvascular disease in subclinical and overt hypertrophic cardiomyopathy

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): British Heart Foundation - Clinical Research Training Fellowship Background Disarray and microvascular disease (MVD) are implicated in adverse events in hypertrophic cardiomyopathy (HCM). Advances in CMR permit quantification of microstructural indices reflecting disarray, and microvascular disease. As novel myosin inhibitors provide promise for disease modification, early and disease-specific biomarkers are a rapidly emerging clinical priority. Purpose Using latest imaging techniques, we investigated MVD and disarray in 3 HCM groups: overt disease, either genotype positive (G+LVH+) or negative (G-LVH+), and subclinical HCM (G+LVH-), exploring relationships to electrical changes and genetic substrate. Methods A 207 subject, multi-centre consortium: 102 patients with overt HCM (52 G+LVH+, 50 G-LVH+), 77 subclinical (G+LVH-) and 28 matched healthy volunteers (HV). All underwent ECG, quantitative perfusion (measuring myocardial blood flow (MBF), perfusion reserve (MPR) and perfusion defects) and cardiac diffusion tensor imaging (cDTI) to investigate for evidence of disarray, measured as fractional anisotropy (FA – the directional variability of diffusion, reflecting myocyte disarray), mean diffusivity (MD – reflecting myocyte packing and intra- and extracellular volume) and absolute second eigenvector angle (E2A –measuring orientation of sheetlets, functional units of myocytes that re-orientate to facilitate wall-thickening). Results Compared to HV, overt HCM had evidence of microstructural alteration (lower FA (suggestive of disarray), higher MD and higher E2A, all p&amp;lt;0.001) and MVD (lower stress MBF and MPR p&amp;lt;0.001). Compared to G+LVH+, G-LVH+ had elevated E2A (64.4°(58.7–66.5) vs 60.1°(55.6–63.7 p = 0.006)). Perfusion defects were found in all G+ but not all G- overt disease (100%(52/52) vs 82%(41/50) p = 0.001). Compared to HV, subclinical HCM (G+LVH-) had evidence of microstructural alteration (lower FA suggestive of disarray, higher MD and higher E2A, all p&amp;lt;0.001) and MVD (reduced stress MBF (2.43±0.52 vs 2.77±0.62ml/g/min p = 0.006) with perfusion defects in 29% (vs 0 HV p = 0.001)). Microstructural markers and MVD were independently associated, in both overt and subclinical disease (overt: E2A and stress MBF: β=-0.29, p = 0.002; subclinical: those with perfusion defects (vs without) had lower FA &amp; higher E2A). Disarray markers and MVD independently associated with pathological ECG abnormalities in both overt and subclinical disease, after adjustment for degree of fibrosis and LVH (overt: FA odds ratio (OR) for abnormal ECG=3.2, p = 0.014; stress MBF OR=2.8, p = 0.013; subclinical: FA OR=3.4, p = 0.006, MPR OR=4.0 p = 0.008). Conclusions In Hypertrophic Cardiomyopathy, sarcomere mutation carriers without hypertrophy have microstructural alterations and microvascular disease that are detectable, correlate, and associate with pathological ECG changes. These are more prominent once LVH is present, with genotype positive and genotype negative overt disease patients having differing phenotypes.

Classifying hypertension mediated left ventricular hypertrophy phenotypes from the 12-lead electrocardiogram using machine learning

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): British Heart Foundation Pat Merriman Clinical Research Training Fellowship Background Hypertension is the commonest cause of left ventricular hypertrophy (LVH), an established independent predictor of cardiovascular morbidity and mortality. Four distinct LVH phenotypes with varying prognostic implications have been reported using cardiac magnetic resonance (CMR) LV mass to volume ratio: normal LV, LV remodelling, eccentric LVH and concentric LVH. Current electrocardiogram (ECG) criteria can detect LVH but their ability to differentiate between hypertension mediated LVH phenotypes is unknown. Purpose The aim of this study was to classify hypertension mediated LVH phenotypes using 12-lead electrocardiogram (ECG) and clinical data for cost-effective patient stratification. Methods 24,535 hypertensive participants from UK Biobank imaging study were categorised into the CMR-defined LVH phenotypes. ECG biomarkers with a physiological association with LVH (including QRS biomarkers, Sokolow-Lyon and Cornell voltage) were extracted from the 12-lead ECG of each participant using in-house algorithms. Vascular risk factors known to be associated with LVH were also ascertained from the clinical data of each participant. Classification models integrating ECG biomarkers and clinical data were built using logistic regression, support vector machine (SVM) and random forest (RF). The dataset was split into 80% train and 20% test sets for performance measurement. Ten-fold cross validation was applied and the training set was downsampled to the minority class. Results Among the participants (mean age ± standard deviation 65.3 ± 7.4 years), 23,312 (95.0%) had normal LV, 900 (3.7%) LV remodelling, 220 (0.8%) eccentric LVH and 103 (0.4%) concentric LVH. R wave amplitude V5, S wave amplitude V3 and QT duration V6 (P&amp;lt;0.001) were the top ECG biomarkers and systolic blood pressure (p&amp;lt;0.001) the top clinical predictor of LVH phenotypes (Figure 1). Classification with logistic regression had an accuracy of 77% (sensitivity 55%, specificity 85%, Area under the receiver operator curve [AUC] 0.76), SVM 80% accuracy (sensitivity 61%, specificity 87%, AUC 0.75) and RF 75% accuracy (sensitivity 49%, specificity 83%, AUC 0.75). ECG biomarkers enhanced model performance of all classifiers, compared to using clinical data alone. Conclusion A combination of automatically extracted ECG biomarkers and clinical data were able to discriminate the hypertension mediated LVH phenotypes. An advanced classification approach improves selection of hypertensive patients with LVH, thereby adding prognostic value to traditional risk models. We are currently validating our findings in an external population and using deep learning for comparison.