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Author: Brian S McGowan, PhD

AMPEL BioSolutions and ArcheMedX Form Partnership Aimed at Improving Success Rate of Clinical Trials

CHARLOTTESVILLE – AMPEL BioSolutions, a leading translational medicine and clinical operations company and ArcheMedX, a digital platform for effective online health care education and training programs, today announced a new collaboration to transform clinical trial recruitment and retention by enabling research sites to more effectively educate and continually engage clinical staff and patients.

The partnership will address the challenges with patient recruitment and retention for clinical trials by developing a new model for improving communication and education across study sites. By combining AMPEL’s extensive clinical expertise with the award-winning ArcheMedX e-learning and analytics platform, AMPEL and ArcheMedX will ensure that principal investigators, trial coordinators, clinical staff, and patients are well informed and continually engaged throughout the trial.

Dr. Peter Lipsky, MD, CEO and chief medical officer of AMPEL BioSolutions said, “This collaboration directly addresses the major challenge in clinical trials in the United States, namely patient recruitment, by engaging sites directly and providing the education and team building foundation that is essential for success.”

This partnership is the culmination of years of independent efforts by both organizations to improve clinical outcomes through distinctly unique solutions.

“Clinical trials are essential to advancing the quality of care, and we have already seen the impact more effective education, communication, and engagement can have on study sites,” said Joel Selzer, co-founder and CEO of ArcheMedx. Through this collaboration, we can dramatically lower operational costs and improve the probability for a successful trial.”

In recent years, patient recruitment and retention for clinical trials has become increasingly difficult as 15 to 20 percent of trial sites never enroll a single patient, and 90 percent of study sites often fail to meet their enrollment goals. Since patient enrollment has a heavy cost and is critical to the success of a trial, there have been numerous attempts to identify the underlying challenges and offer potential solutions.

Study sites face obstacles in identifying, recruiting, and retaining patients. In addition, the overwhelming majority of patients are unaware a trial may be an option and/or have not been provided with sufficient education about the potential value and benefit the trial may provide. Patient involvement and clinical site engagement are essential for clinical trial success and both will be the focus of this new initiative.

About AMPEL BioSolutions

AMPEL is a recognized leader in translational and precision medicine and has designed, organized and analyzed a number of successful proof of concept clinical trials.

About ArcheMedX

ArcheMedX powers hundreds of more engaging and effective online education and training programs for the nation’s leading healthcare organizations.

New Partnership

Both headquartered in Charlottesville, VA, a thriving biosciences, technology, and startup ecosystem, AMPEL Biosciences and ArcheMedX are well positioned to combine forces and dramatically improve the success rate of clinical trials across the country.

Contacts: Kate Vega, Communications Dir of AMPEL BioSolutions (434-326-8272) or Joel Selzer, CEO ArcheMedX (434-260-1850)

RESOURCE: Patient Recruitment and Enrollment in Clinical Trials

Have you ever had trouble enrolling patients for a study? If you answered “yes” then you’re not alone. Most trials end up having to double their original timelines to meet enrollment goals, and 48% of sites under-enroll study volunteers. These delays in drug development cost a lot of money, but when it comes to finding the right participants, patient recruitment is easier said than done.

via Patient Recruitment and Enrollment in Clinical Trials Infographic.

RESOURCE: How Can We Encourage Participation in Clinical Trials?

Failed clinical trials come at a huge cost to their pharmaceutical sponsors. Many trial sites fail to enroll more than a single patient—up to 60% of oncology trials, according to Covance, for example. Yet they estimate it costs a sponsor $50,000 for a site start-up, with a loss of almost $2 billion between 2006-2010 from non-performing sites.

Did you know that only 3% of patients with cancer⁠ participate in clinical trials? Although we have an aging population and cancer rates increase with age, this dismal participation rate hasn’t budged in recent years. What factors are at play?

The biggest barrier in recruitment is lack of encouragement or support from the attending physician. Many physicians simply are unaware of clinical trials that might benefit their patient. Further, with the increasing pressure to see patients more and more quickly, they simply don’t have the time to engage in lengthy discussions with patients. Many are also concerned about lack of control—it is critical that the trial physician communicate regularly with the primary physician.

There is a huge lack of awareness about clinical trials. In a 2000 Harris Interactive survey, 80% of cancer patients were unaware of clinical trial options. In a 2013 Zogby survey, more than half of patients were still unaware of trials. Only a quarter learned of trials from their physician.

READ MORE… How Can We Encourage Participation in Clinical Trials?.

ABSTRACT: Exploratory Study of Rural Physicians’ Self-Directed Learning Experiences in a Digital Age

INTRODUCTION:
The nature and characteristics of self-directed learning (SDL) by physicians has been transformed with the growth in digital, social, and mobile technologies (DSMTs). Although these technologies present opportunities for greater “just-in-time” information seeking, there are issues for ensuring effective and efficient usage to compliment one’s repertoire for continuous learning. The purpose of this study was to explore the SDL experiences of rural physicians and the potential of DSMTs for supporting their continuing professional development (CPD).
METHODS:
Semistructured interviews were conducted with a purposive sample of rural physicians. Interview data were transcribed verbatim and analyzed using NVivo analytical software and thematic analysis.
RESULTS:
Fourteen (N = 14) interviews were conducted and key thematic categories that emerged included key triggers, methods of undertaking SDL, barriers, and supports. Methods and resources for undertaking SDL have evolved considerably, and rural physicians report greater usage of mobile phones, tablets, and laptop computers for updating their knowledge and skills and in responding to patient questions/problems. Mobile technologies, and some social media, can serve as “triggers” in instigating SDL and a greater usage of DSMTs, particularly at “point of care,” may result in higher levels of SDL. Social media is met with some scrutiny and ambivalence, mainly because of the “credibility” of information and risks associated with digital professionalism.
DISCUSSION:
DSMTs are growing in popularity as a key resource to support SDL for rural physicians. Mobile technologies are enabling greater “point-of-care” learning and more efficient information seeking. Effective use of DSMTs for SDL has implications for enhancing just-in-time learning and quality of care. Increasing use of DSMTs and their new effect on SDL raises the need for reflection on conceptualizations of the SDL process. The “digital age” has implications for our CPD credit systems and the roles of CPD providers in supporting SDL using DSMTs.

via Exploratory Study of Rural Physicians’ Self-Directed Learning Experiences in a Digital Age. – PubMed – NCBI.

MANUSCRIPT: Continuing Professional Development via Social Media or Conference Attendance: A Cost Analysis

BACKGROUND:
Professional development is essential in the health disciplines. Knowing the cost and value of educational approaches informs decisions and choices about learning and teaching practices.
OBJECTIVE:
The primary aim of this study was to conduct a cost analysis of participation in continuing professional development via social media compared with live conference attendance.
METHODS:
Clinicians interested in musculoskeletal care were invited to participate in the study activities. Quantitative data were obtained from an anonymous electronic questionnaire.
RESULTS:
Of the 272 individuals invited to contribute data to this study, 150 clinicians predominantly from Australia, United States, United Kingdom, India, and Malaysia completed the outcome measures. Half of the respondents (78/150, 52.0%) believed that they would learn more with the live conference format. The median perceived participation costs for the live conference format was Aus $1596 (interquartile range, IQR 172.50-2852.00). The perceived cost of participation for equivalent content delivered via social media was Aus $15 (IQR 0.00-58.50). The majority of the clinicians (114/146, 78.1%, missing data n=4) indicated that they would pay for a subscription-based service, delivered by social media, to the median value of Aus $59.50.
CONCLUSIONS:
Social media platforms are evolving into an acceptable and financially sustainable medium for the continued professional development of health professionals. When factoring in the reduced costs of participation and the reduced loss of employable hours from the perspective of the health service, professional development via social media has unique strengths that challenge the traditional live conference delivery format.

via Continuing Professional Development via Social Media or Conference Attendance: A Cost Analysis. – PubMed – NCBI.

RESOURCE: No evidence to back idea of learning styles

Generally known as “learning styles”, it is the belief that individuals can benefit from receiving information in their preferred format, based on a self-report questionnaire. This belief has much intuitive appeal because individuals are better at some things than others and ultimately there may be a brain basis for these differences. Learning styles promises to optimise education by tailoring materials to match the individual’s preferred mode of sensory information processing.Teachers must ditch ‘neuromyth’ of learning styles, say scientists Read moreThere are, however, a number of problems with the learning styles approach. First, there is no coherent framework of preferred learning styles. Usually, individuals are categorised into one of three preferred styles of auditory, visual or kinesthetic learners based on self-reports. One study found that there were more than 70 different models of learning styles including among others, “left v right brain,” “holistic v serialists,” “verbalisers v visualisers” and so on. The second problem is that categorising individuals can lead to the assumption of fixed or rigid learning style, which can impair motivation to apply oneself or adapt.Finally, and most damning, is that there have been systematic studies of the effectiveness of learning styles that have consistently found either no evidence or very weak evidence to support the hypothesis

via No evidence to back idea of learning styles | Letter | Education | The Guardian.

ABSTRACT: Are Surgeons Born or Made? A Comparison of Personality Traits and Learning Styles Between Surgical Trainees and Medical Students.

OBJECTIVE:
Medical students and surgical trainees differ considerably in both their preferential learning styles and personality traits. This study compares the personality profiles and learning styles of surgical trainees with a cohort of medical students specifically intent on pursuing a surgical career.
DESIGN:
A cross-sectional study was conducted contrasting surgical trainees with medical students specifying surgical career intent. The 50-item International Personality Item Pool Big-Five Factor Marker (FFM) questionnaire was used to score 5 personality domains (extraversion, conscientiousness, agreeableness, openness to experience, and neuroticism). The 24-item Learning Style Inventory (LSI) Questionnaire was used to determine the preferential learning styles (visual, auditory, or tactile). χ(2) Analysis and independent samples t-test were used to compare LSI and FFM scores, respectively.
SETTING:
Surgical trainees from several UK surgical centers were contrasted to undergraduate medical students.
PARTICIPANTS:
A total of 53 medical students who had specifically declared desire to pursue a surgical career and were currently undertaking an undergraduate intercalated degree in surgical sciences were included and contrasted to 37 UK core surgical trainees (postgraduate years 3-4).
RESULTS:
The LSI questionnaire was completed by 53 students and 37 trainees. FFM questionnaire was completed by 29 medical students and 34 trainees. No significant difference for learning styles preference was detected between the 2 groups (p = 0.139), with the visual modality being the preferred learning style for both students and trainees (69.8% and 54.1%, respectively). Neuroticism was the only personality trait to differ significantly between the 2 groups, with medical students scoring significantly higher than trainees (2.9 vs. 2.6, p = 0.03).
CONCLUSIONS:
Medical students intent on pursuing a surgical career exhibit similar personality traits and learning styles to surgical trainees, with both groups preferring the visual learning modality. These findings facilitate future research into potential ways of improving both the training and selection of students and junior trainees onto residency programs.

via Are Surgeons Born or Made? A Comparison of Personality Traits and Learning Styles Between Surgical Trainees and Medical Students. – PubMed – NCBI.

MANUSCRIPT: Usage of 3D models of tetralogy of Fallot for medical education: impact on learning congenital heart disease

Background

Congenital heart disease (CHD) is the most common human birth defect, and clinicians need to understand the anatomy to effectively care for patients with CHD. However, standard two-dimensional (2D) display methods do not adequately carry the critical spatial information to reflect CHD anatomy. Three-dimensional (3D) models may be useful in improving the understanding of CHD, without requiring a mastery of cardiac imaging. The study aimed to evaluate the impact of 3D models on how pediatric residents understand and learn about tetralogy of Fallot following a teaching session.

Methods

Pediatric residents rotating through an inpatient Cardiology rotation were recruited. The sessions were randomized into using either conventional 2D drawings of tetralogy of Fallot or physical 3D models printed from 3D cardiac imaging data sets (cardiac MR, CT, and 3D echocardiogram). Knowledge acquisition was measured by comparing pre-session and post-session knowledge test scores. Learner satisfaction and self-efficacy ratings were measured with questionnaires filled out by the residents after the teaching sessions. Comparisons between the test scores, learner satisfaction and self-efficacy questionnaires for the two groups were assessed with paired t-test.

Results

Thirty-five pediatric residents enrolled into the study, with no significant differences in background characteristics, including previous clinical exposure to tetralogy of Fallot. The 2D image group (n = 17) and 3D model group (n = 18) demonstrated similar knowledge acquisition in post-test scores. Residents who were taught with 3D models gave a higher composite learner satisfaction scores (P = 0.03). The 3D model group also had higher self-efficacy aggregate scores, but the difference was not statistically significant (P = 0.39).

Conclusion

Physical 3D models enhance resident education around the topic of tetralogy of Fallot by improving learner satisfaction. Future studies should examine the impact of models on teaching CHD that are more complex and elaborate.

via Usage of 3D models of tetralogy of Fallot for medical education: impact on learning congenital heart disease.

ABSTRACT: Enhancing the connection between the classroom and the clinical workplace: A systematic review.

INTRODUCTION:
Although medical students are increasingly exposed to clinical experiences as part of their training, these often occur parallel with, rather than connected to, their classroom-based learning experiences. Additionally, students seem to struggle with spontaneously making the connection between these spheres of their training themselves. Therefore, this systematic review synthesized the existing evidence about educational interventions that aim to enhance the connection between learning in the classroom and its application in the workplace.
METHODS:
Electronic databases (AMED, CINAHL, EMBASE, ERIC, Medline, RDRB, PsycINFO and WoS) were screened for quantitative and qualitative studies investigating educational interventions that referenced a connection between the classroom and workplace-based experiences within undergraduate, graduate or postgraduate medical education.
RESULTS:
Three types of interventions were identified: classroom to workplace interventions, workplace to classroom interventions, and interventions involving multiple connections between the two settings. Most interventions involved a tool (e. g. video, flow chart) or a specific process (e. g. linking patient cases with classroom-based learning content, reflecting on differences between what was learned and how it works in practice) which aimed to enhance the connection between the two settings.
DISCUSSION:
Small-scale interventions can bring classroom learning and workplace practice into closer alignment. Such interventions appear to be the necessary accompaniments to curricular structures, helping bridge the gap between classroom learning and workplace experience. This paper documents examples that may serve to assist medical educators in connecting the classroom and the workplace.

via Enhancing the connection between the classroom and the clinical workplace: A systematic review. – PubMed – NCBI.

ABSTRACT: The role of morbidity and mortality rounds in medical education: a scoping review.

CONTEXT:
There is increasing focus on how health care professionals can be trained effectively in quality improvement and patient safety principles. The morbidity and mortality round (MMR) has often been used as a tool with which to examine and teach care quality, yet little is known of its implementation and educational outcomes.
OBJECTIVES:
The objectives of this scoping review are to examine and summarise the literature on how the MMR is designed and delivered, and to identify how it is evaluated for effectiveness in addressing medical education outcomes.
METHODS:
A literature search of the PubMed, MEDLINE, PsycInfo and Cochrane Library databases was conducted for articles published from 1980 to 1 June 2016. Publications in English describing the design, implementation and evaluation of MMRs were included. A total of 67 studies were identified, including eight survey-based studies, four literature reviews, one ethnographic study, three opinion papers, two qualitative observation studies and 49 case studies of education programmes with or without formal evaluation. Study outcomes were categorised using Donald Moore’s framework for the evaluation of continuing medical education (CME).
RESULTS:
There is much heterogeneity within the literature regarding the implementation, delivery and goals of the MMR. Common design components included explicit programme goals and objectives, the case selection process, case presentation models and some form of case analysis. Evaluation of CME outcomes for MMR were mainly limited to learner participation, satisfaction and self-assessed changes in knowledge.
CONCLUSIONS:
The MMR is widely utilised as an educational tool to promote medical education, patient safety and quality improvement. Although evidence to guide the design and implementation of the MMR to achieve measurable CME outcomes remains limited, there are components associated with positive improvements to learning and performance outcomes.

via The role of morbidity and mortality rounds in medical education: a scoping review. – PubMed – NCBI.