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Purpose: Many diversity, equity, and inclusion initiatives assume that attainment of a racially diverse healthcare workforce will translate to increased diversity elsewhere in the healthcare system (e.g., leadership roles or academic authorship). We sought to investigate these trends over time by examining the evolution of physician demographics in the USA, in concert with demographic changes in US authorship in US medical journals from 1990 to 2020 across 25 specialties., Methods: We reviewed all articles indexed in PubMed, with a primary author affiliation located in the USA and limited to journals based in the USA, relative to the proportion of medical professionals in the CMS National Provider Registry. We employed a previously peer-reviewed/validated algorithm called "averaging-of-proportions" that probabilistically predicts racial identity from surname using the US Census to assess the relationship between diversity among medical professionals and diversity in medical journal authorship., Results: Data reveals a sharp disconnect between the demographic breakdown of physicians and authors. Despite an increase in the number of Black physicians (from 8.5% in 2005 to 9.1% in 2020), there has been a decrease in Black early-career authorship from 7.2% in 1990 to 5.8% in 2020. The percentage of Black early-career authors across all specialties in 2020 is lower than the average per specialty in 1990. Similar trends were noted for Black senior authorship, decreasing from 7.6% in 1990 to 6.2% in 2020, as well as a plateau in Hispanic authorship over the same time interval despite an increasing number of Hispanic physicians., Conclusion: Modest advances in physician diversity have not translated to increased diversity in academic authorship. Increasing diversity requires initiatives focused beyond recruitment of underrepresented minorities to medical schools or residencies., (© 2023. W. Montague Cobb-NMA Health Institute.)

Consistent implementation and measurement of patient engagement initiatives across the industry have remained aspirational and elusive despite strong interest in adopting patient-centric approaches. One factor contributing to this inertia stems from a lack of standardized implementation of patient engagement activities, which varies widely from company to company, making it difficult to track and measure. Further, empirical evidence mapping the impact of patient engagement capabilities on clinical research outcomes has remained sparse. To address this gap, the Drug Information Association (DIA) and Tufts Center for the Study of Drug Development (Tufts CSDD) at the Tufts University School of Medicine developed and administered an assessment tool that companies can use to not only evaluate their organization's patient engagement capabilities and implementation preparedness but can also measure the impact of such activities on trial outcomes. Results showed that while most organizations are providing logistical support to increase patient engagement in the form of travel stipends, accommodation, and financial incentives, most are not implementing more involved forms of patient engagement such as gathering patient input through patient input panels or patient steering committees. This paper discusses the process for designing and administering this assessment tool, the results of the assessment, and future implications., (© 2023. The Author(s), under exclusive licence to The Drug Information Association, Inc.)

Metabolomics is a discipline that offers a comprehensive analysis of metabolites in biological samples. In the last decades, the notable evolution in liquid chromatography and mass spectrometry technologies has driven an exponential progress in LC-MS-based metabolomics. Targeted and untargeted metabolomics strategies are important tools in health and medical science, especially in the study of disease-related biomarkers, drug discovery and development, toxicology, diet, physical exercise, and precision medicine. Clinical and biological problems can now be understood in terms of metabolic phenotyping. This overview highlights the current approaches to LC-MS-based metabolomics analysis and its applications in the clinical research., (© 2021. Springer Nature Switzerland AG.)

Background: MD-PhD programs confer degrees that empower medical doctors with in-depth scientific skills to contribute to biomedical research and academic medicine, alongside clinical practice. Whilst the career options and research opportunities related to graduates following these programs in the US are well documented, little is known about their European counterparts. In this article, we studied graduates who had completed the MD-PhD program at the University of Geneva between 2010 and 2019., Methods: A cross-sectional survey was performed in April 2019, targeting all medical doctors who had obtained the MD-PhD degree from the University of Geneva since 2010. Demographics, opinions, and career outcomes of the MD-PhD graduates were assessed through an online anonymous questionnaire., Results: Twenty-one questionnaires were collected from 31 MD-PhD graduates (response rate 65.5%). Most respondents (57.1%) had performed an MD-PhD training in basic sciences; however, only 14.3% had pursued this type of research thereafter. Most of the respondents held a position at a University hospital (90.5%), although a significant number of them were no longer involved in research in their current position (28.6%). 85.7% mentioned obstacles and challenges in combining clinical duties with research. Despite this, the majority (85.7%) declared that the MD-PhD degree had given them advantages in their career path, granting access to clinical and academic positions, as well as funding., Conclusions: Graduates from the MD-PhD program in Geneva were for the most part, satisfied with their training. However, because of the challenges and obstacles in combining clinical duties with research, the implementation of research activities in their current position proved difficult.

Primary care is at the forefront of healthcare delivery. It is the site of disease prevention and health management and serves as the bridge between communities and the health care system As ethnographers of primary care, in this article we discuss what is gained by situating anthropological inquiry within primary care. We articulate how anthropologists can contribute to a better understanding of the issues that emerge in primary care. We provide a review of anthropological work in primary care and offer empirical data from two ethnographic case studies based in the United States, one focused on social risk screening in primary care and the other examining the diagnosis and care of people with dementia in primary care. Through these cases, we demonstrate how research of and within primary care can open important avenues for the study of the multidimensionality of primary care. This multidimensionality is apparent in the ways the medical field addresses the social and structural experiences of patients, scope of practice and disciplinary boundaries, and the intersection of ordinary and extraordinary medicine that emerge in the care of patients in primary care.

Abstract Background Patient and Public Involvement (PPI) is increasingly recognized as an essential aspect of clinical research, particularly for ensuring relevancy and impact of research to those most affected. This study addresses the gap in involving older patients, particularly nursing home residents, in the research process by exploring motivations, expectations, and experiences of nursing home residents in Bremen, Germany, involved in PPI for developing a clinical trial on polypharmacy. Methods Two Patient Advisory Boards (PABs) were established in nursing homes as part of the INVOLVE-Clin project. A Patient Advocate (PA) facilitated communication between nursing home residents and researchers. A qualitative case study approach was employed, involving semi-structured interviews and group discussions with nursing home residents and researchers. Data was analyzed using structured qualitative content analysis. Results The study found varied motivations and expectations between nursing home residents and researchers. Nursing home residents valued the social interaction and the opportunity to voice their health concerns, while researchers aimed to incorporate patients’ perspectives into study design. The PA was considered crucial in facilitating communication between nursing home residents and researchers. Challenges included the complexity of the study topic and the need for methodological adjustments to suit nursing home residents´ cognitive abilities. Generally, PAB participation was experienced to provide mental stimulation and increased confidence among nursing home residents in discussing their medication management. The PAB’s influence led to the decision not to conduct a polypharmacy study. Discussion The findings underscore the importance of flexible approaches to PPI, particularly when involving older nursing home residents. Methodological adjustments, such as tailoring content and structure of PABs, and the inclusion of additional boards for diverse perspectives, are vital for effective involvement. The study also highlights the need for ongoing innovation in PPI methods to ensure meaningful engagement of older patients in clinical research. Conclusion This study contributes essential insights into the practical implementation of PPI with nursing home residents, highlighting the need for patient-centric approaches that recognize their unique challenges and contributions. These findings are critical for shaping scientifically robust but also socially relevant and impactful research, especially in an aging society.

Abstract Background In Europe and elsewhere in the world, activities are taking place to improve the awareness of children and adolescents (hereinafter: adolescents) regarding their rights and obligations in autonomous decision-making about their own medical treatment and participation in clinical research. Methods The cross-sectional survey of adolescents was carried out using an anonymous online questionnaire. We obtained consent from the Commission of the Republic of Slovenia for Medical Ethics. Participating young people were invited through the network of primary and secondary schools, the Society of Dystrophy of Slovenia and through the dissemination of electronic messages. The online questionnaire was open from April 25 to May 6, 2023. Young people aged 13 to 20 joined the survey. The association between several factors and awareness of the minimum age limit was tested by univariate logistic regression. All statistical testing was performed at a significance level of 0.05. Results The responses of 458 respondents were analysed, of which 281 were male. Only 8.3% of participating adolescents knew the age limit set by law for autonomous decision-making about medical treatment at 15 years old. Most answered that a medical institution should inform them about their rights (62.4%). Only 5.02% responded that they do not need their parents’ consent when making decisions; 2.6% of respondents answered that they autonomously decided to undergo treatment without their parents’ knowledge. The majority obtained information about treatment from a doctor (more than 70%); 42.8% were in favour of new forms of treatment, especially chronic patients (more than 70%); 44.8% had already heard about clinical research, most of them through the media (55.4%); 70% of the respondents answered correctly about making an autonomous decision about participation in research at the age of 18. About three-quarters (75.6%) of respondents who had heard of clinical research believe that an individual should be paid for participating. Conclusions Our research showed insufficient awareness of the age limit of adolescents regarding medical treatment decisions and clinical research. The prevailing view is that health professionals should inform young people more about their rights. Most adolescents believe they should be paid to participate in clinical research.

Abstract Introduction Patient oriented research (POR) invites patients to partner with researchers, clinicians, and other stakeholders, incorporating diverse perspectives to generate scientific evidence meaningful to all parties involved. We adopted a POR approach for this study evaluating the feasibility of conducting a randomized control trial of a novel tri-compartment offloader brace for knee osteoarthritis. We involved patients as partners to enhance study design, implementation and interpretation of key outcomes. Approach Patient involvement consisted of two patient leaders and five patient advisors. Patients participated in 2 virtual focus groups to discuss study outcomes, protocol, results and knowledge translation. Patients were involved in all aspects of the research cycle. Outcomes Patient feedback resulted in changes to study design, documentation, participant recruitment, data collection, results interpretation and knowledge dissemination, improving the participant experience and aligning study outcomes with patient priorities. Study participants showed a high level of protocol adherence and follow-up rates were excellent. We experienced several unexpected benefits including genuine friendships, a deeper understanding of the patient experience, a more pragmatic approach to clinical research, and leadership opportunities for patients. Recommendations We agreed on POR “non-negotiables” to ensure a positive experience for everyone, including creating a safe and comfortable environment, being genuinely receptive to patient feedback, and providing appropriate supports for patients. We strongly recommend that researchers (1) involve patients as early as possible, (2) provide ample and equal opportunities for all patients to be involved, and (3) address system hierarchy by involving patients as equals and fully considering all patient ideas from the beginning of the project. Conclusions While POR is a learning process that is often more challenging than the traditional clinical research approach, the benefits are well worth the additional time and effort required to do it well. Over time, our team experienced a cultural shift and evolution from a top-down research approach to a more inclusive approach considering patient voices as equal to those of researchers. Patient involvement in all aspects of the research process, from question development to results interpretation and dissemination is integral to clinical research advancing equitably.

Objective·To analyze the development trend and current situation of high-level clinical research at Shanghai Jiao Tong University School of Medicine (SJTUSM) from 2015 to 2023, and to summarize the strategies for improving clinical research capability of SJTUSM, aiming to provide reference and inspiration for medical universities to promote high-level clinical research.Methods·Papers published by first authors from SJTUSM or its affiliated hospitals during this period were retrieved in the Web of Science core collection database. General descriptive methods were used to quantify the number of clinical research papers, registered clinical trials, clinical research talent teams, and the current status of clinical research cooperation. Bibliometric methods were used to visualize the international collaboration and topic distribution of retrieved clinical research papers. The differences in the number of clinical research publications, Q1 publications, publications in top clinical medical journals, and full-time researchers between the periods of 2015‒2018 and 2019‒2023 were compared and analyzed.Results·From 2015 to 2023, a total of 9 468 clinical research papers were published by SJTUSM or its affiliated hospitals as the first author′s institution, showing an increasing trend year by year. During this period, the number of Q1 publications of SJTUSM′s clinical research, publications in top clinical medical journals, clinical studies registered on the United States Clinical Trial Registry website, clinical studies registered on the Chinese Clinical Trial Registry website, clinical guidelines and expert consensus publications, full-time research team members, and newly added national-level talents all showed an overall upward trend. Tumors, cardiovascular and cerebrovascular diseases, major chronic diseases, and mental illnesses were the main research hotspots. A total of 1 308 papers (13.82%) were international collaborative papers. Developed countries/regions such as the United States (733 papers), Australia (137 papers), and the United Kingdom (99 papers) were closely cooperating with SJTUSM. From 2019 to 2023, there was a significant increase in the number of clinical research papers, Q1 publications, publications in top clinical medical journals, and newly added full-time research team members in affiliated hospitals compared to the period from 2015 to 2018 (all P

Hepatocellular carcinoma (HCC) is a significant global health challenge, requiring innovative methods to improve patient survival. Due to different disease backgrounds, different HCC management guidelines have been developed, especially in the field of surgical treatment, with the aim of reducing the risk of incidence and enhancing the therapeutic effect. Focusing on the progress and challenges in the development of surgical management strategies for HCC in recent years, this article systematically elaborates on the research and clinical application of precision surgical treatment, including improvement of the surgical evaluation system, breakthroughs in surgical techniques, and updates in perioperative treatment concepts. In addition, clinical research on surgical treatment for HCC has received unprecedented attention. The conclusions of innovative clinical trials in surgery will provide important guidance for the development of practice guidelines and the selection of appropriate treatment strategies for HCC patients.

Background Diabetes has a high incidence rate and many complications, which was an urgent public health problem, but the prevention and management is still not ideal. Objective To observe the effect of Three Division management on metabolic indicators and self-management levels of diabetes patients with different courses of disease. Methods One hundred and 81 type 2 diabetes patients from April 2021 to April 2022 were managed by the mode of Three Division management and followed up for more than 6 months in Shenzhen Hospital Guangzhou University of Chinese Medicine (Futian). The patients were grouped according to the course of disease (Group A: course of disease5-10 years; Group D: course of disease>10 years) ; In outpatient, the three-division team composed of traditional Chinese medicine practitioners, endocrinologists and caregivers carries out comprehensive treatment such as physique identification, complication screening, medicine, food, exercises and emotion intervention; When patients are at home, the caregivers carry out intelligent management through intelligent Glucose meter equipment and mobile phone APP. We collected changes in blood glucose and body weight indicators in patients with different disease courses after six months of management. Additionally, we used a questionnaire to gather common issues in patient self-management and fill out the Summary of Diabetes Self-Care Activities Measure-6 (SDSCA-6) . Results Through the management of the Three Division management, Group A patients showed significant improvement in reducing fasting blood glucose and postprandial 2-hour blood glucose after the intervention (P

Objective To summarize the clinical registration data of endodontic diseases registered in ClinicalTrials.gov in the United States and Chinese Clinical Trial Registry (ChiCTR), and analyze the registration characteristics at home and abroad. Methods We searched the clinical studies related to endodontic disease registered in the two databases from January 1, 2000, to August 20, 2023. We extracted and analyzed the information from clinical studies related to endodontic diseases. The extracted content included information on the registration region, registration year, trial title, research direction, sample size, trial progress, study type, trial design, blinding method, clinical trial phase, and participating institutions. Results The two databases contained a total of 536 191 registered items, of which 634 were endodontic diseases. Clinical trials in the registry of endodontic diseases involved 43 countries, of which the top three were Egypt (188 items), China (130 items), and the America (46 items). In addition, the number of registrations of clinical trials on endodontic diseases has significantly increased since 2015. The research directions were mainly pulposis (434 items), caries (106 items), and periapical diseases (77 items), which mostly involved etiology, drug intervention, surgical intervention, new technology, and new materials. Moreover, there were 430 clinical trials (67.82%) with a sample size < 100 and 185 (29.18%) with a sample size of 100-999. The progress status at the time of registration showed the largest number of completed trials, accounting for 286 items (45.11%), followed by unknown (125 items), recruiting (110 items), and not yet recruiting (81 items). The main research types were intervention studies (546 items, 86.12%), and the main design model was randomized parallel controlled trials (473 items, 74.61%). Additionally, 423 items (66.72%) were marked using the blind method, mainly double-blind trials (195 items), followed by other/unmarked (123 items, 19.40%) and open study (88 items, 13.88%). Furthermore, the largest number of items in the study phase were marked other/unlabeled (388 items), followed by phaseⅡ study (69 items) and preliminary study (62 items). Additionally, 611 items (96.37%) were clinical trials with a number of participating institutions < 3, and 23 items (3.63%) had a number of participating institutions ≥ 3. Conclusion The number of clinical trials registered for endodontic diseases is generally on the rise, but it is still relatively small. The quality of the study design needs to be enhanced, and the registration information in the study phase needs to be improved. Moreover, the number of multicenter trials is small. In the future, we should fully mobilize the talent advantages of well-known stomatology majors in China, take the lead in conducting high-quality, multi-center clinical research, and realize the transformation of results.

Abstract: Background Research is key to quality healthcare. Clinicians should possess adequate research capacity to generate evidence. This study aimed to evaluate the research capacity of pediatricians in Nigeria. Methods: The study was a cross- sectional using a questionnaire developed from the Research Capacity Assessment Framework. Information on previous research work, challenges encountered, and utilization of research outcome were obtained. The data was analyzed using SPSS version 20. Qualitative variables were grouped under thematic headings. Results: Paediatricians who had received grants for research were 21 (19.4%). Those whose research outcomes had informed policy and practice were 20 (18.2%). Less than 40% of the participants had received training on research capacity areas. Conclusion: The research capacity among pediatricians was low partly due to underfunding and lack of research training programs. Improvement on government fund allocation for research and introduction of short research trainings programs will improve research capacity in Nigeria.

Pancreatic surgery is characterized by great trauma, difficult operation, high risk and high complication rate. Minimally invasive, refined and standardized pancreatic surgery is the future trend. With its advantages of high precision, high safety, and more realistic and clear operating field, robotic pancreatic surgery has gradually become the preferred method of pancreatic surgery worldwide. In the past 10 years, more than a dozen large pancreas centers in China have matured to carry out robotic pancreatic surgery, including pancreaticoduodenectomy, pancreaticocaudectomy, pancreatic tumor enucleation, middle pancreatectomy, total pancreatectomy, pancreaticodectomy with duodenum preserved and other pancreatic surgery methods. However, there are still some problems in robotic pancreatic surgery, such as complex system construction, lack of force feedback, inadequate imaging fusion, and immature remote operation. Pancreatic surgeons should continue to carry out high-quality clinical studies on robotic pancreatic surgery to verify its safety and effectiveness, and standardize robotic pancreatic surgery with the accumulation of experience.

Abstract Glioma is the most common malignant tumor in central nervous system, with significant health burdens to patients. Due to the intrinsic characteristics of glioma and the lack of breakthroughs in treatment modalities, the prognosis for most patients remains poor. This results in a heavy psychological and financial load worldwide. In recent years, cannabidiol (CBD) has garnered widespread attention and research due to its anti-tumoral, anti-inflammatory, and neuroprotective properties. This review comprehensively summarizes the preclinical and clinical research on the use of CBD in glioma therapy, as well as the current status of nanomedicine formulations of CBD, and discusses the potential and challenges of CBD in glioma therapy in the future.

India’s clinical trial landscape has witnessed rapid growth over the period, with the recent introduction of remote trial patient monitoring utilising technologies like Artificial Intelligence (AI). The vast and diverse population, combined with well-established medical infrastructure and skilled professionals, makes India an ideal location for conducting clinical research. Many international pharmaceutical companies have chosen to outsource their operations to India as well. However, despite India emerging as a significant hub for clinical trials, recruiting participants still presents unique challenges. This review aimed to shed light on the hurdles faced in recruiting participants in Indian clinical trials and explore potential solutions to bridge this gap. It has been highlighted that overcoming the challenges in recruiting participants in Indian clinical trials requires a multi-faceted approach involving various stakeholders. Along with the powerful steps taken by the government in reforming policies and regulatory norms, certain innovative and effective strategies need to be designed to streamline the processes of participant recruitment.

Burnout in the medical workforce is a growing global concern. Visual arts-based interventions can be a novel way to mitigate burnout and bolster resilience in medicine. Improving tolerance of ambiguity and uncertainty has been associated with decreased rates of burnout in clinicians. No known systematic review exists summarizing the evidence behind the use of visual arts-based interventions to mitigate burnout in clinicians. The authors conducted a systematic literature review of PubMed, EMBASE, and CINAHL in November 2022 using the terms: art, medicine, burnout, and uncertainty. The authors review the evidence for the effects of visual arts-based interventions on clinician burnout. The search identified 58 articles, of which 26 met study inclusion criteria and were assessed by 2 reviewers. These studies reported mixed methods assessments of changes in burnout, empathy, and stress. Overall, visual arts-based interventions promoted empathy, connectedness, and tolerance of ambiguity and had positive effects on burnout; however, some results were mixed. Visual arts-based interventions to mitigate burnout show promise, and additional research should focus on feasibility and longer-term outcomes.

Background In Uganda where the burden of HIV-associated cryptococcal meningitis is high, conventional amphotericin B deoxycholate has been standard to manage patients with cryptococcal meningitis in research settings. However, liposomal amphotericin B (AmBisome) is now available via the efforts of UNITAID. We sought to describe our nursing experience using AmBisome within a clinical trial for cryptococcal meningitis. Methods We describe the experience of using single-dose 10mg/kg liposomal amphotericin B from the perspective of a research nurse in Uganda. Second, we described the process of preparing and administering amphotericin. Third, we assessed the nursing time required for the administration of daily amphotericin B versus single-dose liposomal amphotericin. Fourth, we discuss the major challenges faced while using liposomal amphotericin B. Results We provide estimates for the nursing time required for reconstituting, filtering, diluting and administering liposomal amphotericin B and a visual aid for nursing tasks. Based on five trained nurses, the process of reconstitution and filtration lasts an average of 52 minutes (Range: 40 to 60 minutes), to reconstitute a mean of 11 (range: 8 to 15) 50mg vials (median weight 55kg). Overall, less nursing time was required for single-dose administration than for daily amphotericin B dosing. From a nursing perspective, liposomal amphotericin B was preferable to amphotericin B deoxycholate due to its reduced infusion reactions and other toxicities. Conclusions Single-dose liposomal amphotericin B is a better alternative to daily amphotericin B. In addition to less toxicity, nosocomial infections, reduced hospital stay, and the potential for lower hospitalisation costs, the nursing implications should not be discounted. Quality nursing care is a finite resource in low- and middle-income countries, and single-dose amphotericin B reduced the nursing time required for the care of patients with cryptococcal meningitis.

BackgroundDecades of research have transformed hemophilia from severely limiting children's lives to a manageable disorder compatible with a full, active life, for many in high-income countries. The direction of future research will determine whether exciting developments truly advance health equity for all people with hemophilia (PWH). National Hemophilia Foundation (NHF) and American Thrombosis and Hemostasis Network conducted extensive inclusive all-stakeholder consultations to identify the priorities of people with inherited bleeding disorders and those who care for them.Research design and methodsWorking group (WG) 1 of the NHF State of the Science Research Summit distilled the community-identified priorities for hemophilia A and B into concrete research questions and scored their feasibility, impact, and risk.ResultsWG1 defined 63 top priority research questions concerning arthropathy/pain/bone health, inhibitors, diagnostics, gene therapy, the pediatric to adult transition of care, disparities faced by the community, and cardiovascular disease. This research has the potential to empower PWH to thrive despite lifelong comorbidities and achieve new standards of wellbeing, including psychosocial.ConclusionsCollaborative research and care delivery will be key to capitalizing on current and horizon treatments and harnessing technical advances to improve diagnostics and testing, to advance health equity for all PWH.

Izabela Gudewicz, Justyna Hajtuch, Renata Zaucha Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, PolandCorrespondence: Izabela Gudewicz, Medical University of Gdansk, Marii Sk&lstrok;odowskiej-Curie 3a Street, Gdansk, Poland, Tel +48 797 377 893, Email izabelagudewicz@gumed.edu.plAbstract: The entire clinical trial process is a perfectly orchestrated team. It took many years before centers started hiring clinical trial coordinators. The centers that decided to do so noted not only positive aspects from the technical side of the study, but also from the side of the participants - which are the patients. The aim of the publication was to collect literature data showing the work of the coordinator in the centers and its impact on increasing the effectiveness of the study. The comparison additionally included the importance of the coordinator’s role on patient recruitment and perceptions. The centers analyzed, showed the impact of the coordinator on their center’s research at approximately: 99.1% in China (knowledge of patient rights), 80% in Italy (increasing the quality of the clinical trial conducted) and 70% in South Korea (impact on reducing patient withdrawal of consent). Those teams that worked without the support of a coordinator gained less trust among patients, which affected recruitment and retention of participants. The coordinator’s influence on study management resulted in better organization of the study. Conclusions reached can support the development of centers and thus clinical trials around the world. Hiring a coordinator not only has an impact on improving the management of the study, but also on increasing the number of patients included, and thus increasing the therapeutic options in medicine. This paper aims to compile existing literature concerning the responsibilities of clinical trial coordinators and subsequently advocate for the value they bring to enhancing the efficacy and efficiency of clinical trials.Keywords: study coordinator, clinical research, clinical trials, management, patients

Abstract Background Simulation 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. Methods Standard 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. Results Seventy-eight undergraduates involved the clinical trial simulation and reported improvement of 1.60 (95% CI, 1.48, 1.80, P

ObjectiveThis study aimed to determine the post-matriculation perceptions of interns and faculty who participated in the 2020-2021 virtual interview process and how their expectations of the program and the applicants, respectively, aligned with reality.Design, setting, and participantsPublished surveys on virtual interviewing were reviewed and modified to design two surveys, for interns and for faculty who interviewed. Interns and faculty members from the Departments of Surgery and Medicine at one institution who participated in the 2020-2021 virtual interview process completed the surveys four to six months after the start of the academic year. Following survey completion, surgical interns from the same application cycle participated in one in-person focus group nine months after the start of the academic year to clarify points raised in the surveys.ResultsForty-six interns and faculty members responded to the survey (subgroup response rates ranging from 13-30%) and ten interns participated in the focus group (participation rate 100%). Most faculty and intern participants found that expectations formed during virtual interviews were accurate. However, our respondents noted limitations to virtual interviews that reduced their usefulness, including challenges with unnatural social interactions, understanding city fit, and getting a sense of resident and program culture. Participants provided possible solutions to address these challenges.ConclusionsOverall, this mixed-methods study at a single institution found that perceptions from virtual interviews were generally accurate but with some limitations. We describe several opportunities to improve the virtual interview process and optimize the application experience.

This study determined whether initiation of pharmacologic treatment was delayed for newly diagnosed osteoporosis patients during the COVID-19 pandemic. 1,189 patients ≥50 years with newly diagnosed osteoporosis using dual-energy x-ray absorptiometry (DXA) screening at a single academic institution were included. Patients with previous osteoporosis were excluded. Patients diagnosed between March 1, 2018-January 31, 2020 (pre-pandemic cohort, n = 576) were compared to those diagnosed between March 1, 2020-January 31, 2022 (pandemic cohort, n = 613). Age, sex, race, ethnicity, ordering providers (primary vs specialty), and pharmacological agents were evaluated. Primary outcomes included proportion of patients prescribed therapy within 3 and 6-months of diagnosis, and mean time from diagnosis to treatment initiation. The pre-pandemic cohort had more White patients (74.3 vs 68.4%, p = .02) and no differences between remaining demographic variables. Only 40.5% of newly diagnosed patients initiated pharmacologic therapy within 6 months. Patients treated at 3-months (31.8 vs 35.4%, p = 0.19) and 6-months (37.8 vs 42.9, p = 0.08) were comparable between cohorts (47.2 vs 50.2% p = 0.30). Mean time from diagnosis to treatment initiation was similar (46 vs 45 days, p = 0.72). There were no treatment differences based on gender, race, or ethnicity or between ordering providers (65.1 vs 57.4% primary care, p = 0.08). Bisphosphonates were most often prescribed in both cohorts (89% vs 82.1%). This is the first study assessing COVID-19's impact on pharmacologic treatment of newly diagnosed osteoporosis. 40.5% of newly diagnosed patients were treated pharmacologically within six months of diagnosis, and the pandemic did not significantly affect treatment rates.

Abstract Gene editing is a growing gene engineering technique that allows accurate editing of a broad spectrum of gene‐regulated diseases to achieve curative treatment and also has the potential to be used as an adjunct to the conventional treatment of diseases. Gene editing technology, mainly based on clustered regularly interspaced palindromic repeats (CRISPR)–CRISPR‐associated protein systems, which is capable of generating genetic modifications in somatic cells, provides a promising new strategy for gene therapy for a wide range of human diseases. Currently, gene editing technology shows great application prospects in a variety of human diseases, not only in therapeutic potential but also in the construction of animal models of human diseases. This paper describes the application of gene editing technology in hematological diseases, solid tumors, immune disorders, ophthalmological diseases, and metabolic diseases; focuses on the therapeutic strategies of gene editing technology in sickle cell disease; provides an overview of the role of gene editing technology in the construction of animal models of human diseases; and discusses the limitations of gene editing technology in the treatment of diseases, which is intended to provide an important reference for the applications of gene editing technology in the human disease.

Background About a quarter of the world's population suffers from metabolic syndrome (MetS). In recent years, the prevalence of MetS in China has also increased year by year, posing a serious threat to life and health. Traditional chinese medicine has the advantages of multi-target and multi-link in the treatment of MetS, but there is a lack of high-quality randomized controlled studies and real-world studies in clinical practice. Objective To observe the effects of Gehu Tiaozhi Decoction on waist circumference (WC), body weight, body fat percentage (BFP) and glucose and lipid metabolism in patients with MetS. Methods From June 2021 to November 2022, 84 patients with MetS were prospectively selected from the outpatient department and inpatient department of LongHua Hospital Shanghai University of Traditional Chinese Medicine. The subjects were randomly divided into Gehu group (42 cases) and control group (42 cases). The patients in the Gehu group were treated with Gehu Tiaozhi Decoction (Pueraria lobamle radix 6 g, Dendrobium officinale 6 g). The patients were fasted once in the morning and once in the evening, 1 bag each time, taken orally for 8 weeks. The control group was treated with placebo granules. The patients were fasted once in the morning and once in the evening, 1 bag each time, taken orally for 8 weeks. During the intervention, the two groups of patients were given the same health education (including dietary regimen and exercise prescription guidance). After 8 weeks of intervention, the WC, body weight, BMI, BFP, triglyceride (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C) and fasting blood glucose (FBG) were compared between the two groups. Results Finally, 41 patients in the Gehu group and 41 patients in the control group completed the 8-week intervention study. No statistically significant differences of WC, body weight, BMI or BFP was found between the two groups before treatment (P>0. 05). The differences of WC, body weight, BMI and BFP between the two groups before and after treatment were statistically significant (P0. 05). The differences of TG, TC and FBG between the two groups before and after treatment were statistically significant (P

Background In Uganda where the burden of HIV-associated cryptococcal meningitis is high, conventional amphotericin B deoxycholate has been standard to manage patients with cryptococcal meningitis in research settings. However, liposomal amphotericin B (AmBisome) is now available via the efforts of UNITAID. We sought to describe our nursing experience using AmBisome within a clinical trial for cryptococcal meningitis. Methods We describe the experience of using single-dose 10mg/kg liposomal amphotericin B from the perspective of a research nurse in Uganda. Second, we described the process of preparing and administering amphotericin. Third, we assessed the nursing time required for the administration of daily amphotericin B versus single-dose liposomal amphotericin. Fourth, we discuss the major challenges faced while using liposomal amphotericin B. Results We provide estimates for the nursing time required for reconstituting, filtering, diluting and administering liposomal amphotericin B and a visual aid for nursing tasks. Based on five trained nurses, the process of reconstitution and filtration lasts an average of 52 minutes (Range: 40 to 60 minutes), to reconstitute a mean of 11 (range: 8 to 15) 50mg vials (median weight 55kg). Overall, less nursing time was required for single-dose administration than for daily amphotericin B dosing. From a nursing perspective, liposomal amphotericin B was preferable to amphotericin B deoxycholate due to its reduced infusion reactions and other toxicities. Conclusions Single-dose liposomal amphotericin B is a better alternative to daily amphotericin B. In addition to less toxicity, nosocomial infections, reduced hospital stay, and the potential for lower hospitalisation costs, the nursing implications should not be discounted. Quality nursing care is a finite resource in low- and middle-income countries, and single-dose amphotericin B reduced the nursing time required for the care of patients with cryptococcal meningitis.

Training healthcare professionals in research methodology is essential to promote research and innovation. This is particularly relevant in India, where there is a wealth of potential drug candidates from Indian Traditional Medicine (TM) systems that await exploration and scientific validation using modern medicine principles. Surprisingly, there is a lack of reported activities to train modern medicine practitioners in TM research in the literature. Recognising this need, a structured training program was planned and conducted under the auspices of the Indian Council of Medical Research (ICMR) to train modern medicine practitioners in TM research. A survey was conducted among modern medicine practitioners to assess training gaps and identify key areas to be covered in the workshop modules. The workshop received a positive response, as evidenced by the numerous registration applications and positive feedback from participants. The present article shares the experiences of conducting the pilot workshop, which may serve as a valuable resource for planning similar workshops.

The BraYn association aims to bolster young neuroscientists’ research endeavors through collaborative support, fundraising assistance, and events promoting knowledge exchange and collaboration across Europe. Central to its mission is the annual BraYn conference, tailored for PhD students, postdocs, junior PIs, neurologists, and clinicians. This gathering champions cooperation, offering talks by key figures, educational workshops, and opportunities for attendees to present their work, compete for grants, and engage in international scientific experiences. The conference, established in 2018, has grown substantially in attendance and industry support and was adapted during the pandemic with virtual editions. The last sixth edition in Naples (27–29 September 2023) attracted over 300 delegates, focusing on peer-to-peer discussions, interdisciplinary collaboration, and interaction with renowned speakers, solidifying its place as a flagship event for Europe’s budding neuroscience researchers.

Objective·To investigate the current situation and problems of the construction of clinical research talents team in China, and propose targeted improvement strategies.Methods·Self-designed questionnaires were made after literature review, expert interviews and two rounds of Delphi. An online questionnaire survey was conducted on 583 clinical research-related personnel from hospitals, biomedical enterprises, medical colleges and government departments in 27 provinces, cities and autonomous regions, and the survey results were analyzed.Results·A total of 583 questionnaires were collected, 579 of which were valid, with an effective rate of 99.3%. The research results showed that: ① The lack of clinical research talents and the poor development environment of talents were the key factors restricting the high-level clinical research in China. ② Among the respondents, 72.7% of them were dissatisfied (very dissatisfied, dissatisfied and average) with the current training of clinical research talents. The main problems included lack of high-level research talents and a professional support team; the current performance evaluation system was monotonous, the salary and incentive were not profitable for clinical research, and medical personnel engaged in clinical research and support staff lacked promotion channels, etc. ③ The improvement strategies included systematically improving the clinical research ability of medical personnel, improving the clinical research training curriculum system, adopting different training methods in the school education stage and in-service education stage, and attaching more importance to the two teams′ training, clinical research physicians and clinical research methodology professionals.Conclusion·Currently, it is urgent to expand the number of excellent medical students and improve the courses of clinical research methodology and relevant laws and regulations, encourage experienced research-oriented doctors to guide new staff in research projects, systematically improve the scientific research ability of current medical personnel, pay more attention to training of standardized implementation of clinical research projects, topic selection design and others, gather a high-level team of composite clinical research medical personnel, increase the amount of professionals in clinical research methodology, further attach importance to clinical research, and improve the development environment of clinical research talents from the aspects of professional title promotion, salary, scientific research evaluation, etc, so as to improve the level of clinical research in China.

Background and purpose: Plants have been known and used by different societies since ancient times. The most important applications include nutrition, medicine, and industry. Acorus calamus L. (Acoraceae), is one of the medicinal plants that exists in the Iran and some other ecotypes and is used as a medicinal plant also in China, India, and Greece. Recently, it received attention, however there is lack of information about this medicinal plant. Materials and methods: We performed a search in Scopus, Web of Science, PubMed, and Google Scholar and also traditional medicine books using the following keywords: A. calamus, traditional medicine, modern medicine, laboratory studies, and biological effects. Results: In reliable articles and traditional medicine books, A.calamus was found with many different properties. The aerial parts, roots, and rhizome were reported to have antioxidant, antibacterial, anti-fungal, and anti-inflammatory activities. A.calamus is also used in treating nervous system disorders and in production of nanoparticle and pharmaceutical products. Conclusion: According to many studies, A. calamus has many beneficial properties, but in vitro and in vivo studies are required to investigate its medicinal effects. Also, the plant is originally found in Mazandaran province, north of Iran and it can be used in medicinal and health products.

Castleman disease (CD) is a group of rare and heterogenous hematological diseases included in the 'Rare disease catalogue' of China. Among the different clinical subtypes of CD, idiopathic multicentric Castleman disease (iMCD) is characterized by symptomatic inflammatory symptoms with poor prognosis. Interleukin-6 (IL-6) targeted therapy (eg. siltuximab) is now considered as the most important treatment option according to international and domestic treatment guidelines and consensus. On July 2022, siltuximab became available in Chinese market, heralding the era of IL-6 targeted therapy in China. Thus, it is a good time point to review the state-of-the-art technology in the field of diagnosis and treatment of CD. We also highlight some of the clinical investigations conducted by Chinese researchers.

Abstract Background The COVID-19 pandemic created a complex high-risk clinical research environment with clinical research activities significantly impacted. Clinical research stakeholders adapted rapidly to new clinical practices; PPE, infection control policies, all while engaging with a more unwell patient demographic. The aim of this study is to explore the experiences of conducting clinical research during COVID-19 with clinical research stakeholders. Methods This qualitative study of semi-structured interviews conducted with clinical research stakeholders in an acute Hospital setting across a variety of disciplines; Consultant Geriatrician, Clinical Research Nurse, Occupational Therapy, Physiotherapy. Interviews were fully transcribed prior to reflexive thematic analysis. NVivo software was used to support data management and analysis. Results Three main themes were produced; (1) The challenging COVID-19 clinical research landscape, (2) COVID-19 clinical research communication barriers, and (3) Adaptations and learnings from clinical research during COVID-19. Conclusions This study explored the experiences of conducting clinical research during COVID-19 with clinical research stakeholders examining challenges faced and adaptations required. The findings inform, equip and support clinical research stakeholders in the event of future adverse public health events.

With the rapid development of biomedical science and technology in China, the number of clinical research projects is increasing rapidly, which is accompanied by ethical challenges. In recent years, a number of regional ethics committees have been established in China, and some experience has been gained in regional ethical review, but there is a certain difficulty in implementing it. In response to the difficulties in regional ethical review, the ethical cooperative review mode of medical union with the leading units as the core has been established based on the experience of foreign regional ethical review and the characteristics of the medical consortium structures that have been widely established in the county-level hospitals and prefecture level tertiary hospitals in Jiangsu region. It is expected to give full play to the flexible advantages of regional ethics committees by radiating and promoting the ethical review ability of medical union.

BackgroundThe great majority of severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) infections are mild and uncomplicated, but some individuals with initially mild COVID-19 progressively develop more severe symptoms. Furthermore, there is substantial heterogeneity in SARS-CoV-2-specific memory immune responses following infection. There remains a critical need to identify host immune biomarkers predictive of clinical and immunological outcomes in SARS-CoV-2-infected patients.MethodsLeveraging longitudinal samples and data from a clinical trial (N=108) in SARS-CoV-2-infected outpatients, we used host proteomics and transcriptomics to characterize the trajectory of the immune response in COVID-19 patients. We characterized the association between early immune markers and subsequent disease progression, control of viral shedding, and SARS-CoV-2-specific T cell and antibody responses measured up to 7 months after enrollment. We further compared associations between early immune markers and subsequent T cell and antibody responses following natural infection with those following mRNA vaccination. We developed machine-learning models to predict patient outcomes and validated the predictive model using data from 54 individuals enrolled in an independent clinical trial.ResultsWe identify early immune signatures, including plasma RIG-I levels, early IFN signaling, and related cytokines (CXCL10, MCP1, MCP-2, and MCP-3) associated with subsequent disease progression, control of viral shedding, and the SARS-CoV-2-specific T cell and antibody response measured up to 7 months after enrollment. We found that several biomarkers for immunological outcomes are shared between individuals receiving BNT162b2 (Pfizer-BioNTech) vaccine and COVID-19 patients. Finally, we demonstrate that machine-learning models using 2-7 plasma protein markers measured early within the course of infection are able to accurately predict disease progression, T cell memory, and the antibody response post-infection in a second, independent dataset.ConclusionsEarly immune signatures following infection can accurately predict clinical and immunological outcomes in outpatients with COVID-19 using validated machine-learning models.FundingSupport for the study was provided from National Institute of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID) (U01 AI150741-01S1 and T32-AI052073), the Stanford's Innovative Medicines Accelerator, National Institutes of Health/National Institute on Drug Abuse (NIH/NIDA) DP1DA046089, and anonymous donors to Stanford University. Peginterferon lambda provided by Eiger BioPharmaceuticals.

Mobile health (mHealth) interventions, which require ownership of mobile phones, are being investigated throughout Africa. We estimate the percentage of individuals who own mobile phones in 33 African countries, identify a relationship between ownership and proximity to a health clinic (HC), and quantify inequities in ownership. We investigate basic mobile phones (BPs) and smartphones (SPs): SPs can connect to the internet, BPs cannot. We use nationally representative data collected in 2017-2018 from 44,224 individuals in Round 7 of the Afrobarometer surveys. We use Bayesian multilevel logistic regression models for our analyses. We find 82% of individuals in 33 countries own mobile phones: 42% BPs and 40% SPs. Individuals who live close to an HC have higher odds of ownership than those who do not (aOR: 1.31, Bayesian 95% highest posterior density [HPD] region: 1.24-1.39). Men, compared with women, have over twice the odds of ownership (aOR: 2.37, 95% HPD region: 1.96-2.84). Urban residents, compared with rural residents, have almost three times the odds (aOR: 2.66, 95% HPD region: 2.22-3.18) and, amongst mobile phone owners, nearly three times the odds of owning an SP (aOR: 2.67, 95% HPD region: 2.33-3.10). Ownership increases with age, peaks in 26-40 year olds, then decreases. Individuals under 30 are more likely to own an SP than a BP, older individuals more likely to own a BP than an SP. Probability of ownership decreases with the Lived Poverty Index; however, some of the poorest individuals own SPs. If the digital devices needed for mHealth interventions are not equally available within the population (which we have found is the current situation), rolling out mHealth interventions in Africa is likely to propagate already existing inequities in access to healthcare.

BackgroundBurnout is common among physicians and has detrimental effects on patient care and physician health. Recent editorials call attention to perfectionism in medicine; however, no studies to date have examined the effect of perfectionism on burnout in physicians practicing in the United States. This study examined associations among demographics, perfectionism and personality traits, and burnout among practicing physicians.MethodsThis cross-sectional study included general pediatric and pediatric sub-specialist physicians. Out of the 152 physicians contacted, 69 enrolled (Meanage = 44.16 ± 9.98; 61% female). Emotional exhaustion, depersonalization, and personal accomplishment burnout were assessed via the Maslach Burnout Inventory. Validated instruments were used to measure personality and perfectionism. Data were analyzed using linear regression models.ResultsAcross physicians assessed, 42% reported either high emotional exhaustion burnout or depersonalization burnout. High self-critical perfectionism uniquely predicted both high emotional exhaustion burnout (B = 0.55, 95%CI 0.25-0.85) and depersonalization burnout (B = 0.18, 95%CI 0.05-0.31). Low conscientiousness (B = -6.12; 95%CI, -10.95- -1.28) predicted higher emotional exhaustion burnout and low agreeableness (B = -3.20, 95%CI -5.93- -0.46) predicted higher depersonalization burnout.ConclusionsPerfectionism is understudied among physicians and the current findings suggest that addressing system and individual-level factors that encourage perfectionism is warranted and may reduce risk for physician burnout.