Interest In Clinical Research Research Articles

Abstract 4134772: Optimizing Heart Failure with Preserved Ejection Fraction Management: Quality Review of SGTL2 Inhibitor Use

Heart failure with preserved ejection fraction (HFpEF) remains a diagnostic challenge despite a 50% incidence of HF admissions. H2FPEF tool is a validated scoring system that estimates HFpEF probability with a sensitivity of 69% and positive predictive value of 85%. Despite clinical research interest and therapeutic advances in HFpEF, implementation of therapies remain inconsistent. Currently ACC/AHA guidelines classify sodium-glucose cotransporter 2 inhibitors (SGLT2i) use a 2A recommendation with benefits for reducing hospital admissions. We assess the utilization of current guidelines. An observational retrospective analysis was performed of patients >18 years with a left ventricular ejection fraction of >50% seen in cardiology clinic with an ICD.10 code of diastolic heart failure from January 2022 to 2024 at a large tertiary hospital. Electronic records were reviewed for patient demographics, documentation of heart failure diagnosis, medication list and echocardiogram parameters. Primary outcome was HF related hospitalization. The study screened 79 patients, 51% females and 49% males. 20.2% of the patients were on SGLT2i, a quarter of which were female. Of those on SGLT2i, 56% were on diuretics, 81% had H2FpEF score > 5, 56% had diabetes, and 19% had a HF hospitalization. SGLT2i was stopped in 1 patient due to cost. Of the (63) 79.8% of patients not on SGLT2I, 65% were on diuretics, 90% had H2FPEF score > 5, 23% had diabetes and 32% had a HF hospitalization. 43% were males, with an average age of 71 for males and 62 for females. Ten patients had documented reasons for not being on SGLT2i including CKD, dialysis, yeast infection and denied insurance coverage. Unadjusted effect measures for HF hospitalization (HR 0.59, RRR 40.9%, OR 0.496; p 0.134). As guidelines are readily investigated and updated by expert consensus groups, evaluating practice patterns is key. Unlike other cardiac medications, SGLT2is are primarily initiated by cardiologists and recognizing barriers can identify generalizability of current guidelines. Our data looked at both objective and clinical endpoints for HFPEF diagnosis. Interestingly, women were less often started on SGLT2i and coverage was not a frequent cause for not using SGLT2i. Our quality metric analysis shows a potential protective effect of HF readmission with SGLT2i use in a highly symptomatic cohort, and suggests future directives need to focus on broadening educational reach among cardiologists.

Engaging Nursing Students in Clinical Research Through a Unique Academic-Clinical Partnership.

A unique partnership between two academic medical centers, one with a college of nursing and the other with a clinical research center (CRC), provided professional development hours focusing on clinical research and the clinical research nurse's role to generalist entry master's nursing students. Students with clinical research interests were invited to apply for the 32-hour professional development program scheduled during 4 sequential days. Didactic, observational, and role-playing experiences offered students a picture of the clinical research nurse role, research regulatory processes, and career opportunities postgraduation. Evaluation of the four cohorts who completed the program demonstrated that most participants highly agreed that the program was educational and valuable. Partnering with academic medical centers who have CRCs provides master's-level students with innovative professional development hours that foster their understanding of practice areas (e.g., clinical research, specialty role of the clinical research nurse) that are not part of their coursework. [J Nurs Educ. 2024;63(X):XXX-XXX.].

Neurotoxin-Derived Optical Probes for Elucidating Molecular and Developmental Biology of Neurons and Synaptic Connections. Toxin-Derived Optical Probes for Neuroimaging.

Botulinum neurotoxins (BoNTs) and tetanus toxin (TeTX) are the deadliest biological substances that cause botulism and tetanus, respectively. Their astonishing potency and capacity to enter neurons and interfere with neurotransmitter release at presynaptic terminals have attracted much interest in experimental neurobiology and clinical research. Fused with reporter proteins or labelled with fluorophores, BoNTs and TeTX and their non-toxic fragments also offer remarkable opportunities to visualize cellular processes and functions in neurons and synaptic connections. This study presents the state-of-the-art optical probes derived from BoNTs and TeTX and discusses their applications in molecular and synaptic biology and neurodevelopmental research. It reviews the principles of the design and production of probes, revisits their applications with advantages and limitations and considers prospects for future improvements. The versatile characteristics of discussed probes and reporters make them an integral part of the expanding toolkit for molecular neuroimaging, promoting the discovery process in neurobiology and translational neurosciences.

"Academic Influence and Industry Funding in Nerve Allograft Research: A Co-Authorship Network Analysis".

Clinical use of acellular nerve allografts is rapidly increasing despite limited high-quality, comparative evidence of superiority. Simultaneously, non-research payments to clinicians by the nerve allograft industry exceeds $14,000,000 over the last decade. In this study, the authors hypothesized that nerve allograft-related academic influence would correlate with industry funding. PubMed studies on nerve allografts in plastic and reconstructive surgery journals were reviewed. Using author lists from extracted studies, a co-authorship network was generated and degree centralities - quantitative measurements of influence within a network - were calculated. Open Payments data from the nerve allograft industry was summated for each author. Finally, Pearson correlation and linear regression were used to analyze the relationship between centrality and payments received. 185 studies were included, with 581 unique authors (nodes) and 2,406 co-authorships (ties) between them. Among authors with exceptional network influence (centrality >10, 75th percentile; n=113), 56 were clinicians with valid NPIs and therefore eligible for inclusion in the Open Payments database. 44 (79%) of these authors received at least one payment from the industry. Pearson correlation revealed a moderate (0.4<r<0.6) positive correlation between centrality and payments received (r=0.51, p<0.001). Linear regression demonstrated an estimated 16% increase in total pay per additional unit of centrality (p<0.001; 95% CI [8%, 25%]). There is a significant connection between academic influence and financial support from the nerve allograft industry. Such results warrant discussion concerning conflicts of interest in clinical research and best practices for mitigating potential bias related to commercially backed treatments.

Changes in Rehmanniae Radix processing and their impact on ovarian hypofunction: potential mechanisms of action.

This study evaluates the research developments concerning Rehmanniae Radix in ovarian hypofunction diseases. It explores the processing methods of Rehmanniae Radix, the variations in its compounds before and after processing, the mechanism of Rehmanniae Radix and its active compounds in improving ovarian function, and the advancements in clinical applications of traditional Chinese medicine (TCM) compound that include Rehmanniae Radix. Comprehensive literature search was conducted using databases such as China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database, National Science and Technology Library, the Pharmacopoeia of the People's Republic of China, Pubmed, and the Web of Science Database. The search utilized the following Medical Subject Headings (MeSH) and keywords: "Rehmanniae Radix," "Drying Rehmannia Root," "Rehmannia glutinosa," "Rehmanniae Radix Praeparata," "Traditional Chinese Medicine Processing," "Pharmacological Effects," "Ovarian Aging," "Diminished ovarian reserve," "Premature ovarian insufficiency," "Premature Ovarian Failure," "Ovarian hypofunction diseases". The ancient Chinese medical books document various processing techniques for Rehmanniae Radix. Contemporary research has identified changes in its compounds processing and the resultant diverse therapeutic effects. When processed into Rehmanniae Radix Praeparata, it is noted for its ability to invigorate the kidney. TCM compound containing Rehmanniae Radix is frequently used to treat ovarian hypofunction diseases, demonstrating significant clinical effectiveness. The key changes in its compounds processing include cyclic dilute ether terpene glycosides, phenylethanol glycosides, sugars, and 5-hydroxymethylfurfural. Its pharmacological action is primarily linked to the improvement of granulosa cell proliferation, antioxidative and anti-aging properties, and modulation of the immune and inflammatory microenvironment. Furthermore, Rehmanniae Radix also offers therapeutic benefits for cardiovascular and cerebrovascular diseases, osteoporosis and cognitive dysfunction caused by low estrogen levels. Thereby Rehmanniae Radix mitigates both the short-term and long-term health risks associated with ovarian hypofunction diseases. Processed Rehmanniae Radix has shown potential to improve ovarian function, and its compound prescriptions have a definite effect on ovarian dysfunction diseases. Therefore Rehmanniae Radix was garnering interest for both basic and clinical research, with promising application prospects as a future therapeutic agent for ovarian hypofunction diseases. However, further studies on its toxicology and the design of standardized clinical trials are necessary to fully establish its efficacy and safety.

The association between serum uric acid and low birth weight in advance maternal age women with hypertension: An observational study.

In China, the implementation of 2-child policy since 2015 entitles increasing number of advanced maternal age. Recently, Chinese hypertensive disorders of pregnancy (HDP) in advanced-age women have attracted significant clinical and epidemiological research interest. Previous studies have shown an association between serum uric acid (SUA) levels and low birth weight (LBW) in children. Several studies have reported that advanced maternal age is a risk factor for many complications in pregnancy, including LBW. However, it remains unclear whether SUA affects LBW risk in advanced maternal age mothers with hypertensive diseases. The study was observational in nature. A total of 692 advanced maternal age with hypertension were enrolled in our study. A variety of demographic and vital sign data, laboratory test results, and pregnancy outcomes were collected. Children born with LBW served as the clinical endpoint. On admission, blood samples were taken, and women with advanced maternal ages were divided into 2 groups based on their SUA levels. In order to investigate the association between SUA and LBW, a logistic regression model was used. E-value analysis was used to determine the residual unmeasured confounding. The mean SUA level was increased in advanced maternal age patients with HDP. Of 692 newborns, 244 (35.26%) have LBW. With possible confounders adjusted, high SUA levels were independent risk factors for LBW (odds ratio [OR]2.88, 95% confidence intervals [CI]1.22-6.81), multivariate logistic regression analysis using SUA as a continuous variable recapitulated the pattern (OR 1.01, 95% CI 1.00-1.01). In addition, SUA levels in women with advanced maternal age and hypertension were linearly related to LBW incidence. According to this study, SUA levels in patients with advanced maternal age and HDP are associated with LBW incidence.

The role of the musculoadipose status in the assessment of the risk profile before liver transplantation

Sarcopenia and sarcopenic obesity worsen the prognosis after liver transplantation; however, the assessment of body composition is not yet considered in the evaluation prior to liver transplantation to estimate the risk profile of the recipient. Prehabilitation, which includes the nutritional supplementation and physiotherapy, represents arecent focus of interest in clinical transplantation research. This article gives an overview of the recent knowledge about the role of the musculoadipose status and the available methods for the estimation in the assessment of the recipient's risk profile.

Integration of Clinical Trial Development in Hematology-Oncology Fellowship Training.

Several barriers to physicians becoming clinical investigators exist, including inexperience, lack of available mentors, and inconsistent instructive approaches with varying degrees of participation during training. These barriers cause fewer hematology-oncology fellows to pursue academic careers. A consensus is needed on structuring education in clinical investigation paired with active participation in development of a clinical trial guided by a mentor with the goal of increasing fellow interest in clinical research and pursuit of careers in academic medicine. The clinical trial development (CTD) program was initiated at Washington University School of Medicine in St. Louis in 2002 as a hands-on learning experience for hematology and oncology fellows in the design, implementation, and publication of clinical trials. Each fellow was required to identify a mentor and propose at least 1 prospective investigator-initiated clinical trial. At the time of data abstraction in July 2023, 118 fellows had participated in the CTD program and initiated protocols in a variety of areas according to their interests. Fellows were included in data abstraction if their fellowship began in 2002 through 2021; the program is ongoing, and the most recent class will graduate in 2024. Disease types were evenly distributed between solid tumor oncology (60 [51%]) or classic and malignant hematology (58 [49%]). Ninety-three fellows (79%) obtained institutional review board approval, and 60 (65%) published their results. Among graduating fellows, 67 (66%) secured an academic faculty appointment. Fellows with institutional review board-approved projects had significantly higher odds of obtaining an academic faculty appointment (odds ratio, 4.96; 95% confidence interval, 1.54, 15.98; P = .007).Next StepsNext steps will be to further evaluate the effect of the mentorship network on early career productivity of trainees that graduate and the feasibility of extending the program to another institution.

Evaluation of Pharmacy Students' Understanding of Clinical Trials and Research through Questionnaires Before and After the Hospital Practical Training

A questionnaire survey was conducted to evaluate practical training and improve education on clinical trial and research. This survey was based on the results of questionnaire before and after the practical training undertaken by 240 pharmaceutical students (Kanto region; 1 university, Tokai region; 2 university, Kinki region; 9 university) at Mie University Hospital between 2011 and 2022. In the questionnaire before practical training, lectures in university (n=219, 91%) were the main source of information on clinical trials and research. Fifty-two students (22%) correctly answered the contents of phase 1-4 trials. As an occupation that can perform clinical research coordinator (CRC)'s work, only 7 students (3%) answered that "all medical and non-medical professionals" can perform the CRC's duties. Regarding the understanding of terms related to clinical trials and research, more than 90% of the students understood the meaning of "subjects," "informed consent," and "placebo" even before practical training. Otherwise, even after practical training, students' understanding of "reimbursement," "follow-up period," "audit," or "direct access" was less than 80%. Practical training improved the understanding of terms such as clinical trial (Wilcoxon signed-rank test, p<0.001), clinical research phase 1-4 trials (Wilcoxon signed-rank test, p<0.001), interest in clinical trials and research (McNemar-Bowker test, p<0.001), and understanding of CRC's work (McNemar-Bowker test, p<0.001). We will improve the content of practical training and bequeath the knowledge and importance of drug discovery and development to the next generation.

A Meta-Analysis Approach to Gene Regulatory Network Inference Identifies Key Regulators of Cardiovascular Diseases.

Cardiovascular diseases (CVDs) represent a major concern for global health, whose mechanistic understanding is complicated by a complex interplay between genetic predisposition and environmental factors. Specifically, heart failure (HF), encompassing dilated cardiomyopathy (DC), ischemic cardiomyopathy (ICM), and hypertrophic cardiomyopathy (HCM), is a topic of substantial interest in basic and clinical research. Here, we used a Partial Correlation Coefficient-based algorithm (PCC) within the context of a meta-analysis framework to construct a Gene Regulatory Network (GRN) that identifies key regulators whose activity is perturbed in Heart Failure. By integrating data from multiple independent studies, our approach unveiled crucial regulatory associations between transcription factors (TFs) and structural genes, emphasizing their pivotal roles in regulating metabolic pathways, such as fatty acid metabolism, oxidative stress response, epithelial-to-mesenchymal transition, and coagulation. In addition to known associations, our analysis also identified novel regulators, including the identification of TFs FPM315 and OVOL2, which are implicated in dilated cardiomyopathies, and TEAD1 and TEAD2 in both dilated and ischemic cardiomyopathies. Moreover, we uncovered alterations in adipogenesis and oxidative phosphorylation pathways in hypertrophic cardiomyopathy and discovered a role for IL2 STAT5 signaling in heart failure. Our findings underscore the importance of TF activity in the initiation and progression of cardiac disease, highlighting their potential as pharmacological targets.

How effective are mood stabilizers in treating bipolar patients comorbid with cPTSD? Results from an observational study

BackgroundMultiple traumatic experiences, particularly in childhood, may predict and be a risk factor for the development of complex post-traumatic stress disorder (cPTSD). Unfortunately, individuals with bipolar disorder (BP) are more likely to have suffered traumatic events than the general population. Consequently, cPTSD could be comorbid with BD, and this may negatively affect psychopathological manifestations. To date, no one has explored whether such comorbidity also affects the response to treatment with mood stabilizers in BD patients.ResultsHere, a cross-sectional study was carried out by comparing the response to treatment, measured by the Alda scale, in a cohort of 344 patients diagnosed with BD type I and II, screened for the presence (or absence) of cPTSD using the International Trauma Questionnaire. The main result that emerged from the present study is the poorer response to mood stabilizers in BD patients with comorbid cPTSD compared with BD patients without cPTSD.ConclusionsThe results collected suggest the need for an add-on therapy focused on trauma in BD patients. This could represent an area of future interest in clinical research, capable of leading to more precise and quicker diagnoses as well as suggesting better tailored and more effective treatments.

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.

Opportunities and challenges in using NIH’s Dietary Supplement Label Database for research on non-nutrient ingredients: Use case for ingredients in honeybee products

BackgroundNon-nutrient bioactive ingredients of foods such as bee products are often of interest in preclinical and clinical research to explore their possible beneficial effects. The National Institute of Health’s Dietary Supplement Label Database (DSLD) contains over 165,000 labels of dietary supplements marketed in the United States of America (US), including declarations on labels for many ingredients such as those in honeybee products which have been used in foods and traditional medicines for centuries worldwide and are now also appearing in dietary supplements. MethodsThis article presents a use case for honeybee products that describes and tests the utility of the DSLD and other databases available in the US as research tools for identifying and quantifying the prevalence of such ingredients. It focuses on the limitations to the information on product composition in these databases and describes how to code the ingredients using the LanguaL™ and FoodEx2 classification and description systems and the strengths and limitations of information on honeybee product ingredients, including propolis, bee pollen, royal jelly, beeswax. Results and conclusionsCodes for the ingredients are provided for identifying their presence in LanguaL™ and FoodEx2 classification and description systems used in Europe and elsewhere. The prevalence of dietary supplement products containing these ingredients in DSLD and on the US market is low compared to some other products and ingredients. Unfortunately label declarations in DSLD do not provide quantitative information and so the data can be used only to screen for their presence, but cannot be used for quantitative exposure estimates by researchers and regulators.

Schema therapy in adults with autism spectrum disorder: A scoping review.

Schema therapy (ST) in adults with autism spectrum disorder (ASD) have gained increasing interest in clinical practice and research. However, to date, there has been no synthesis of the literature on ST as treatment for adults with ASD. Through a scoping review, we aim to summarize the emerging research and literature on ST for adults with ASD. A comprehensive literature search of three electronic databases was conducted using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. Publications were included that examined ST in adults with ASD and non-clinical adults with autistic traits. Systematic searches identified a total of 11 publications, all published since 2014, with the majority being conducted by Dutch and Japanese researchers. Of the 11 publications, 1 described an ST-informed social interaction training, 1 was an ST protocol, 2 described conceptual ST models, 2 were case examples, 2 examined early maladaptive schemas (EMSs) and 3 investigated the effectiveness of ST interventions. In summary, the theoretical exploration, practical examples of the application of ST and research findings with preliminary evidence of ST, EMSs and schema modes (SMs) in adults with ASD point towards the potential of ST for the treatment of adults with ASD. The current scoping review highlights preliminary research findings and offers valuable suggestions for clinicians treating adults with ASD. This review underscores the need for development of and research in specialized ST protocols and programmes tailored to adults with ASD with chronic mental conditions, such as personality disorders (PDs).

An expert review of clozapine in Latin American countries: Use, monitoring, and pharmacovigilance

There is growing interest in clozapine clinical use, monitoring, and research, particularly adverse drug reactions (ADRs) other than agranulocytosis. In this study we focused on clozapine pharmacovigilance. Hence, we contacted clinicians and researchers in Latin America and requested information about local psychiatric services, clozapine availability, clinical use, and ADR monitoring with the VigiBase system. Only two countries have the minimum recommended number of psychiatric beds (15 per 100,000 residents): Uruguay (N = 34.9) and Argentina (N = 17). Bolivia is the only country where clozapine is unavailable. Nine out of twenty countries (45 %) reported ADRs to VigiBase. Argentina, Brazil, Chile, Colombia, and Mexico published national guidelines for schizophrenia treatment. Chile is the sole country with clozapine clinics with drug serum monitoring. Ethnicity-related drug titration in not described in package inserts in any country. We examined in detail the 9 most frequent and important clozapine ADRs in the worldwide database (pneumonia, sudden death, cardiac arrest, agranulocytosis, myocarditis, constipation, arrhythmia, seizure, and syncope). These 9 ADRs led to 294 reports with fatal outcomes in Argentina (N = 3), Brazil (N = 3), Chile (N = 2), and Peru (N = 1). Agranulocytosis was reported from 7 countries: constipation or seizures from 8 countries. Only two countries reported pneumonia and one country reported myocarditis. The number of clozapine reports in VigiBase has no relationship to the country's population. All Latin American countries underreport clozapine associated ADRs. Latin American governments, along with clinicians, researchers, and educators, should optimize clozapine use and monitoring for the benefit of people with severe mental and some neurological disorders.

Clinical Research in Prehospital Care: Current and Future Challenges.

Prehospital care plays a critical role in improving patient outcomes, particularly in cases of time-sensitive emergencies such as trauma, cardiac failure, stroke, bleeding, breathing difficulties, systemic infections, etc. In recent years, there has been a growing interest in clinical research in prehospital care, and several challenges and opportunities have emerged. There is an urgent need to adapt clinical research methodology to a context of prehospital care. At the same time, there are many barriers in prehospital research due to the complex context, posing unique challenges for research, development, and evaluation. Among these, this review allows the highlighting of limited resources and infrastructure, ethical and regulatory considerations, time constraints, privacy, safety concerns, data collection and analysis, selection of a homogeneous study group, etc. The analysis of the literature also highlights solutions such as strong collaboration between emergency medical services (EMS) and hospital care, use of (mobile) health technologies and artificial intelligence, use of standardized protocols and guidelines, etc. Overall, the purpose of this narrative review is to examine the current state of clinical research in prehospital care and identify gaps in knowledge, including the challenges and opportunities for future research.

Naturalistic psilocybin use is associated with persisting improvements in mental health and wellbeing: results from a prospective, longitudinal survey.

The classic psychedelic psilocybin, found in some mushroom species, has received renewed interest in clinical research, showing potential mental health benefits in preliminary trials. Naturalistic use of psilocybin outside of research settings has increased in recent years, though data on the public health impact of such use remain limited. This prospective, longitudinal study comprised six sequential automated web-based surveys that collected data from adults planning to take psilocybin outside clinical research: at time of consent, 2 weeks before, the day before, 1-3 days after, 2-4 weeks after, and 2-3 months after psilocybin use. A sample of 2,833 respondents completed all baseline assessments approximately 2 weeks before psilocybin use, 1,182 completed the 2-4 week post-use survey, and 657 completed the final follow-up survey 2-3 months after psilocybin use. Participants were primarily college-educated White men residing in the United States with a prior history of psychedelic use; mean age = 40 years. Participants primarily used dried psilocybin mushrooms (mean dose = 3.1 grams) for "self-exploration" purposes. Prospective longitudinal data collected before and after a planned psilocybin experience on average showed persisting reductions in anxiety, depression, and alcohol misuse, increased cognitive flexibility, emotion regulation, spiritual wellbeing, and extraversion, and reduced neuroticism and burnout after psilocybin use. However, a minority of participants (11% at 2-4 weeks and 7% at 2-3 months) reported persisting negative effects after psilocybin use (e.g., mood fluctuations, depressive symptoms). Results from this study, the largest prospective survey of naturalistic psilocybin use to date, support the potential for psilocybin to produce lasting improvements in mental health symptoms and general wellbeing.

Researcher Experience and Comfort With Telemedicine and Remote Patient Monitoring in Cancer Treatment Trials.

Since the onset of COVID-19, oncology practices across the US have integrated telemedicine (TM) and remote patient monitoring (RPM) into routine care and clinical trials. The extent of provider experience and comfort with TM/RPM in treatment trials, however, is unknown. We surveyed oncology researchers to assess experience and comfort with TM/RPM. Between April 10 and June 1, 2022, we distributed email surveys to US-based members of the American Society of Clinical Oncology (ASCO) whose member records indicated interest or specialization in clinical research. We collected respondent demographic data, clinical trial experience, workplace characteristics, and comfort and experience with TM/RPM use across trial components in phase I and phase II/III trials. TM/RPM was defined as clinical trial-related healthcare and monitoring for patients geographically separated from trial site. There were 141 surveys analyzed (5.1% response rate). Ninety percent of respondents had been Principal Investigators, 98% practiced in a norural site. Most respondents had enrolled patients in phase I (82%) and phase II/III trials (99%). Across all phases and trial components, there was a higher frequency of researcher comfort compared to experience. Regarding remote care in treatment trials, 75% reported using TM, RPM, or both. Among these individuals, 62% had never provided remote care to trial patients before the pandemic. COVID-19 spurred the rise of TM/RPM in cancer treatment trials, and some TM/RPM use continues in this context. Among oncology researchers, higher levels of comfort compared with real-world experience with TM/RPM reveal opportunities for expanding TM/RPM policies and guidelines in oncology research.

Psychometric properties of an Arabic translation of the multidimensional assessment of interoceptive awareness (MAIA-2) questionnaire in a non-clinical sample of Arabic-speaking adults

BackgroundInteroception refers to processes through which the nervous system identifies, analyzes, and integrates the information generated by the physiological state of the body (e.g., from internal organs such as the stomach, heart, or lungs). Despite its potential interest for clinical research and its wide use globally, no Arabic adaptation and validation of the Multidimensional Assessment of Interoceptive Awareness (MAIA-2) questionnaire exists to date. The goal of this study was to examine the psychometric properties of an Arabic translation of the MAIA-2 in a sample of Arabic-speaking community adults from Lebanon. We hypothesized that the Arabic version of the MAIA-2 would yield adequate internal consistency coefficients; the 8-factor structure model would show a good fit to our data, with measurement invariance and good convergent validity.MethodThe Arabic adaptation of the MAIA-2 was developed using the forward–backward translation method. A non-clinical sample of Arabic-speaking adults (n = 359, 59.9% females, mean age = 22.75 years (SD = 7.04)) took part of this validation study. To check if the model was adequate, several fit indices were calculated: the normed model chi-square (χ²/df), the Steiger-Lind root mean square error of approximation (RMSEA), the Tucker-Lewis Index (TLI) and the comparative fit index (CFI). Values ≤ 3 for χ²/df, and ≤ 0.08 for RMSEA, and 0.90 for CFI and TLI indicate good fit of the model to the data.ResultsConfirmatory Factor Analyses corroborated the validity of the original 8-factor structure of the MAIA-2 [χ2/df = 1603.86/601 = 2.67, RMSEA = 0.068 (90% CI 0.064, 0.072), SRMR = 0.058, CFI = 0.903, TLI = 0.892]. Reliability estimates in our sample revealed good internal consistency, with McDonald’s ω coefficients for the subscales ranging from 0.86 to 0.93. Our analyses also revealed measurement invariance of the Arabic MAIA-2 for gender. No statistically significant difference between men and women in all dimensions, except for the not worrying and attention regulation subscales where men scored significantly higher than women. Finally, the Arabic MAIA-2 dimensions showed positive correlations with the intuitive eating dimension “Reliance on Hunger and Satiety Cues”, thus providing support for convergent validity.ConclusionWe contribute the literature by providing the first Arabic adaptation and validation of a measure assessing the multidimensional construct of self-reported interoception. The Arabic MAIA-2 demonstrated good psychometric properties. We thus preliminarily recommend its use to measure the interoceptive awareness construct among Arabic-speaking communities worldwide.

MALAT1 in Liquid Biopsy: The Diagnostic and Prognostic Promise for Colorectal Cancer and Adenomas?

The development of colorectal cancer (CRC) is a multistep process accompanied by the accumulation of mutations that start from specific precancerous lesion - colorectal adenomas (CA). CRC incidence and mortality can be reduced by the early identification of these neoplasm. Colonoscopy is the most widely used screening method for CRC identification. Nowadays, clinical research interest is shifting to the use of liquid biopsy that may help with the early diagnosis of CA and CRC. In our previous study, we identified long non-coding RNA MALAT1 gene amplification associated with the development of CA. This study aimed to describe the potential of MALAT1 expression levels in the adenoma tissue of patients used in the previous study by real-time qPCR. Furthermore, we analysed the plasma samples of an independent group of patients with CA (n=97), CRC (n=101), and cancer-free individuals (CFI, n=48). There was no difference in the MALAT1 expression level between CA patients with or without MALAT1 amplification. However, the plasma MALAT1 expression levels were significantly upregulated in patients with CRC and CA compared to CFI (for both p<0.001). Moreover, a correlation between MALAT1 expression and histological types of adenomas was identified- high-CRC-risk adenomas also displayed the highest MALAT1 expression levels. Furthermore, in CRC patients, MALAT1 levels were associated with a response to therapy. MALAT1 expression levels could serve as a promising circulating biomarker for early CA and CRC diagnosis, and even as a predictor of therapy response in CRC patients.