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Diabetes mellitus in underrepresented racial and ethnic groups (URG) is rapidly increasing in incidence and has worse outcomes than diabetes in non-Hispanic White individuals. Rare and Atypical Diabetes Network (RADIANT) established recruitment targets based on the racial and ethnic distribution of the USA to enroll a diverse study population. We examined participation of URG across RADIANT study stages and described strategies to enhance recruitment and retention of URG.
Materials and Methods:
RADIANT is a multicenter NIH-funded study of people with uncharacterized forms of atypical diabetes. RADIANT participants consent online and progress through three sequential study stages, as eligible.
We enrolled 601 participants with mean age 44 ± 16.8 years, 64.4% female. At Stage 1, 80.6% were White, 7.2% African American (AA), 12.2% other/more than one race, and 8.4% Hispanic. Enrollment of URG was significantly below preset targets across most stages. Referral sources differed by race (p < 0.001) but not ethnicity (p = 0.15). Most AA participants were referred by RADIANT investigators (58.5% vs. 24.5% in Whites), whereas flyers, news, social media, and family or friends were more frequent referral sources for White individuals (26.4% vs. 12.2% in AA). Ongoing initiatives to increase enrollment of URG in RADIANT include engaging with clinics/hospitals serving URG, screening electronic medical records, and providing culturally competent study coordination and targeted advertisement.
There is low participation of URG in RADIANT, potentially limiting the generalizability of its discoveries. Investigations into barriers and facilitators for recruitment and retention of URG in RADIANT, with implications for other studies, are ongoing.
As a result of the COVID-19 pandemic, medical statistics and public health data have become staples of newsfeeds worldwide, with infection rates, deaths, case fatality and the mysterious R figure featuring regularly. However, we don't all have the statistical background needed to translate this information into knowledge. In this lively account, Stephen Senn explains these statistical phenomena and demonstrates how statistics is essential to making rational decisions about medical care. The second edition has been thoroughly updated to cover developments of the last two decades and includes a new chapter on medical statistical challenges of COVID-19, along with additional material on infectious disease modelling and representation of women in clinical trials. Senn entertains with anecdotes, puzzles and paradoxes, while tackling big themes including: clinical trials and the development of medicines, life tables, vaccines and their risks or lack of them, smoking and lung cancer, and even the power of prayer.
Clinical trial participation among historically underrepresented populations remains low in large part due to mistrust of academic institutions and research investigators. Mistrust may be ever greater today given misinformation related to COVID-19. The Research Ambassador Program is an interactive educational workshop delivered by Promotoras de Salud/Community Health Workers and designed to both address common myths, fears, and concerns about research and encourage research participation among underrepresented populations. An evaluation conducted with 819 Latino and Black participants demonstrated a change in behavior and intention to participate in a clinical trial, with half of participants enrolling in a clinical trial research registry.
The purpose of this scoping review is two-fold: to assess the literature that quantitatively measures outcomes of mentorship programs designed to support research-focused junior faculty and to identify mentoring strategies that promote diversity within academic medicine mentoring programs.
Studies were identified by searching Medline using MESH terms for mentoring and academic medicine. Eligibility criteria included studies focused on junior faculty in research-focused positions, receiving mentorship, in an academic medical center in the USA, with outcomes collected to measure career success (career trajectory, career satisfaction, quality of life, research productivity, leadership positions). Data were abstracted using a standardized data collection form, and best practices were summarized.
Search terms resulted in 1,842 articles for title and abstract review, with 27 manuscripts meeting inclusion criteria. Two studies focused specifically on women, and four studies focused on junior faculty from racial/ethnic backgrounds underrepresented in medicine. From the initial search, few studies were designed to specifically increase diversity or capture outcomes relevant to promotion within academic medicine. Of those which did, most studies captured the impact on research productivity and career satisfaction. Traditional one-on-one mentorship, structured peer mentorship facilitated by a senior mentor, and peer mentorship in combination with one-on-one mentorship were found to be effective strategies to facilitate research productivity.
Efforts are needed at the mentee, mentor, and institutional level to provide mentorship to diverse junior faculty on research competencies and career trajectory, create a sense of belonging, and connect junior faculty with institutional resources to support career success.
Clinical research staff play a critical role in recruiting families for pediatric research, but their views are not well described. We aimed to describe how pediatric research staff build trusting research relationships with patients and their families.
We interviewed research staff at one pediatric research institution and its affiliated academic medical center between November 2020 and February 2021. Staff were eligible if they conducted participant recruitment, consent, and/or enrollment for clinical research. We developed our semi-structured interview guide based on a framework for trusting researcher-community partnerships.
We interviewed 28 research staff, with a median age of 28 years (range 22–50) and a median of 5 years of experience (range 1–29). Interviewees identified factors relevant to relationship building across three levels: the individual staff member, the relational interaction with the family, and the institutional or other structural backdrop. Individual factors included how staff developed recruitment skills, their perceived roles, and their personal motivations. Relational factors spanned four stages of recruitment: before the approach, forming an initial connection with a family, building the connection, and following up. Structural factors were related to access and diversity, clinical interactions, and the COVID-19 pandemic.
Research staff discussed tensions and supports with various actors, challenges with the integration of research and clinical care, the importance of voluntariness for building trust, and multiple contributors to inequities in research. These findings reveal the importance of ensuring research staff have a voice in institutional policies and are supported to advocate for patients and families.
Managing healthcare data is a major challenge for today’s medicine. The use of artificial intelligence and big data tools has allowed solving questions related to this topic. However, the wide heterogeneity in the psychiatric consultation record makes the retrospective analysis of these data limited due to a lack of information or differences between specialists.
We aim to develop a platform that allows the structured record of medical care data (based on dementia) while maintaining flexibility and format for its usefulness during clinical practice in psychiatry.
We developed a web-based platform for the structured and semi-structured record of psychiatric evaluation. The instrument is diagnosed-oriented (for our version we used dementia). We used Core outcome sets and expert opinion to identify the relevant outcomes for the attention.
A web-based platform is presented for the care of people with suspected dementia at different levels of care designed with the potential to record information of interest in research but also of clinical utility for closer follow-up.
This strategy allows developing the proposal towards other pathologies of interest. Also, with the integration of recommendation algorithms, a monitoring and recommendation system could be achieved to promote knowledge of psychiatric illness from routine practice. This proposal intends to have an impact by increasing the quality of care, reducing care times, and providing better approaches from primary care systems.
Although antipsychotics were discovered over fifty years ago, it took another decade until dopamine antagonism was demonstrated as central to their clinical effectiveness. Since accumulated evidence implicates the dopamine system in the pathophysiology of schizophrenia, all licensed first-line treatments operate primarily via antagonism of the dopamine D2 receptor. However, dopamine D2 receptor blockade does not effectively treat negative, cognitive and affective symptoms and, in a significant proportion of patients, it does not improve positive symptoms either. Therefore, additional neurochemical targets were considered. The “revised dopamine hypothesis” proposes that positive symptoms emerge due to hyperactive dopamine transmission in mesolimbic areas, while hypoactive dopamine transmission via the mesocortical pathway in the prefrontal cortex is linked to negative, cognitive, and partly affective symptoms. In this context, the role of D3 receptors were recognised. However, there is also evidence for the involvement of other neurotransmitter systems, suggesting that dopamine signalling relies on a suite of receptors that are thought to either facilitate or inhibit neurotransmitter activity through several interconnected neural circuits. Furthermore, there seem to be clusters of symptoms that cross the boundaries of disorders. Symptoms having similar pathophysiology at neurotransmitter level can be treated with the same drug or class of drugs. Thus, one particular drug might be effective in more than one indication. This lecture aims to illustrate the process of a new drug development by explaining how the underlying pathophysiology on receptor level impacts clinical studies and vice versa.
Diversification of the Translational Science workforce is a strategic goal for the National Center for the Advancement of Translational Science (NCATS) program. NCATS has identified the development of translational science education, training, and support for a diverse translational science workforce as key to advancing the growing field of translational science. An annual mixed-methods assessment has been conducted on Common Metrics data submitted by over 60 Clinical & Translational Science Awards (CTSA) programs nationwide and includes metrics addressing recruitment and retention of scientists with particular attention to underrepresented persons and women. This article describes a methodology for the development of From Insights to Action, a resource for guiding program implementation and strategic planning to develop a diverse clinical and translational science workforce. This was informed by the Common Metrics Initiative process and constituted of findings from qualitative interviews of a subset of CTSAs that participated. The dissemination of this guide had several impacts, including providing structural foci for the CTSA Fall 2020 program meeting centered on Diversity, Equity, and Inclusion in translational science; addressing NCATS’ goal of workforce diversity; and understanding the number of diverse graduates still engaged in research.
Identifying and disseminating actionable intelligence is a challenging task that requires thoughtful planning. The National Center for Advancing Translational Sciences instituted the Common Metrics Initiative with the goal of evaluating the Clinical and Translational Science Awards (CTSA) Programs using a standard set of metrics. Initially managed by Tufts University, the Center for Leading Innovation and Collaboration (CLIC) at the University of Rochester began leading this initiative in 2017. In directing this work, CLIC created a framework for communicating and disseminating data insights. Insights to Inspire emerged from the need to share strategies and lessons learned to improve metric performance at the local level to a network of 60+ academic research institutions. Insights to Inspire employs a mixed methods approach for translating data into actionable intelligence. A series of blogs, webinars, and webcasts were designed to communicate metric-specific strategies used by individual sites to the broader CTSA consortium. A dissemination plan to expand the reach beyond metric stakeholders utilized focused communications including social media channels, network newsletters, and presentations at national meetings. This framework serves as a blueprint for other national evaluation programs interested in a systematic approach to using data insights for continuous improvement.
The COVID-19 pandemic’s need for life-saving treatments and a "warp speed" vaccine challenged the National Institutes of Health’s Clinical and Translational Science Award (CTSA) recipients to improve their methods and processes in conducting clinical research. While CTSA recipient, New Jersey Alliance for Clinical and Translational Science (NJ ACTS), responded to this call to action with significant clinical research milestones, a comprehensive understanding of regulatory metrics during the COVID-19 pandemic is uncertain. The objective of this research is to identify, compare, and contrast metrics that illustrate the effectiveness of NJ ACTS’s research mobilization efforts during COVID-19.
Data were collected from the Institutional Review Board (IRB), the Clinical Research Units (CRUs), and the Office of Research and Sponsored Programs (ORSP). IRB data detailed the volume and types of protocols approved and turnaround time (TAT) for approval in 2020 vs. 2019. CRU data examined study metrics of adult and pediatric clinical trials across 2018-2020. ORSP data documented awards received in 2019 and 2020
Analysis revealed a 95% increase in IRB-approved studies in 2020, with a significant decrease in TAT for COVID-19 studies. All CRUs observed a median 5.2-fold increase in the enrollment of adult and pediatric participants for COVID-19-related research. Study income was 106% and 196% greater than 2019 and 2018, respectively, with more than half funded through federal sponsors and 89% for COVID-19 trials. ORSP data revealed that 9% of awards and 26% of 2020 funding were COVID-19 studies.
This study demonstrates that NJACTS effectively responded to challenges posed by the pandemic
Clinical research is complex, and research-related terms can be challenging to understand. Clear, supportive communication with patients, potential study participants, and their caregivers must be prioritized by healthcare providers as well as investigators and their research teams. In clinical research, health literacy best practices support the ethical tenets of respect, justice, and beneficence. Plain language advances the understanding of informed consent documents, as well as comprehension of educational information, recruitment materials, study instructions, and study results summaries, among others. Further, a more collaborative research partnership is fostered when study participants are given understandable materials, while a lack of understanding can delay accrual and decrease adherence. We launched a pilot initiative to develop a consensus-driven, plain language clinical research glossary to promote clarity, consistency, and transparency across clinical research stakeholder groups. The resulting resource, described herein, is intended to be used widely to support a greater understanding of clinical research and empower study participants. Considerations for expansion are also discussed.
To improve maternal health outcomes, increased diversity is needed among pregnant people in research studies and community surveillance. To expand the pool, we sought to develop a network encompassing academic and community obstetrics clinics. Typical challenges in developing a network include site identification, contracting, onboarding sites, staff engagement, participant recruitment, funding, and institutional review board approvals. While not insurmountable, these challenges became magnified as we built a research network during a global pandemic. Our objective is to describe the framework utilized to resolve pandemic-related issues.
We developed a framework for site-specific adaptation of the generalized study protocol. Twice monthly video meetings were held between the lead academic sites to identify local challenges and to generate ideas for solutions. We identified site and participant recruitment challenges and then implemented solutions tailored to the local workflow. These solutions included the use of an electronic consent and videoconferences with local clinic leadership and staff. The processes for network development and maintenance changed to address issues related to the COVID-19 pandemic. However, aspects of the sample processing/storage and data collection elements were held constant between sites.
Adapting our consenting approach enabled maintaining study enrollment during the pandemic. The pandemic amplified issues related to contracting, onboarding, and IRB approval. Maintaining continuity in sample management and clinical data collection allowed for pooling of information between sites.
Adaptability is key to maintaining network sites. Rapidly changing guidelines for beginning and continuing research during the pandemic required frequent intra- and inter-institutional communication to navigate.
No established risk prediction tool exists in United Kingdom and Irish Paediatric Cardiology practice for patients undergoing cardiac catheterisation. The Catheterisation RISk score for Paediatrics is used primarily in North American practice to assess risk prior to cardiac catheterisation. Validating the utility and transferability of such a tool in practice provides the opportunity to employ an already established risk assessment tool in everyday practice.
To ascertain whether the Catheterisation RISk score for Paediatrics assessment tool can accurately predict complications within United Kingdom and Irish congenital catheterisation practice.
Clinical and procedural data including National Institute for Cardiovascular Outcomes Research derived outcome data from 1500 patients across five large congenital cardiology centres in the United Kingdom and Ireland were retrospectively collected. Catheterisation RISk score for Paediatrics were then calculated for each case and compared with the observed procedural outcomes. Chi-square analysis was used to determine the relationship between observed and predicted events.
Ninety-eight (6.6%) patients in this study experienced a significant complication as qualified by National Institute for Cardiovascular Outcomes Research classification. 4% experienced a moderate complication, 2.3% experienced a major complication and 0.3% experienced a catastrophic complication resulting in death. Calculated Catheterisation RISk score for Paediatrics scores correlated well with all observed adverse events for paediatric patients across all CRISP categories. The association was also transferable to adult congenital heart disease patients in lower Catheterisation RISk score for Paediatrics categories (CRISP 1–3).
The Catheterisation RISk score for Paediatrics score accurately predicts significant complications in congenital catheterisation practice in the United Kingdom and Ireland. Our data validated the Catheterisation RISk score for Paediatrics assessment tool in five congenital centres using National Institute for Cardiovascular Outcomes Research-derived outcome data.
The success of any clinical research team is dependent on hiring individuals with the experience and skill set needed for a specific research project. Strategies to improve the ability of human resource (HR) recruiters to screen and advance qualified candidates for a project will result in improved initiation and execution of the project.
HR recruiters play a critical role in matching research applicants to the posted job descriptions and presenting a list of top candidates to the PI/hiring manager for interview and hiring consideration.
Creating guidelines to screen for applicant qualification based on resumes when clinical research positions have multiple levels of expertise required is a complex process of discovery, moving from subjective rationale for rating individual resumes to a more structured less biased evaluation process. To improve the hiring process of the research workforce, we successfully developed guidelines for categorizing research coordinator applications by level from beginner to advanced.
Through guideline development, we provide a framework to reduce bias and improve the matching of applicant resumes to job levels for improved selection of top candidates to advance for interviewing. Improved applicant to job matching offers an advantage to reduce hiring time, anticipate training needs, and shorten the timeline to active project engagement. These guidelines can form the basis for initial screening and ultimately matching individual qualities to project-specific needs.
Little is known about the number of minors enrolled in clinical research today. IRB administrators at leading pediatric medical centers were surveyed regarding studies with minors. Analyses were descriptive in nature with adaptive Bayesian bootstrap imputation used with missing data. Officials from 17/41 (41.5%) pediatric research centers responded: 74,204 active studies were estimated, 29,078 (39%) included minors, and 6574 (23%) were “more than minimal risk.” Minors accounted for 0.7–2.87M research subjects. Pediatric medicine desperately needs a more accurate and reliable reporting system for tracking the recruitment, retention, and involvement of minors in clinical research.
Understanding patient and caregiver experiences is a critical component of the conception, design, and implementation of clinical research studies. The “Database of Individual Patient Experiences” (DIPEx) is an innovative, evidence-based approach for eliciting rich information about health experiences. We conducted a formative evaluation with 14 pediatric oncology researchers to assess the value of using data from a DIPEx study on patient and caregiver experiences with childhood cancer to inform patient-centered research in pediatric oncology. Participants identified barriers to incorporating patient perspectives and experiences into their research and how the DIPEx approach could be leveraged to facilitate this practice.
In this paper, we address how the COVID-19 pandemic has impacted informed consent for clinical research through examining experiences within Clinical and Translation Science Award (CTSA) institutions. We begin with a brief overview of informed consent and the challenges that existed prior to COVID-19. Then, we discuss how informed consent processes were modified or changed to address the pandemic, consider what lessons were learned, and present research and policy steps to prepare for future research and public health crises. The experiences and challenges for CTSA institutions offer an important perspective for examining what we have learned about informed consent and determining the next steps for improving the consent process.
The coronavirus disease 2019 (COVID-19) created major disruptions at academic centers and healthcare systems globally. Clinical and Translational Science Awards (CTSA) fund hubs supported by the National Center for Advancing Translational Sciences provideinfrastructure and leadership for clinical and translational research at manysuch institutions.
We surveyed CTSA hubs and received responses from 94% of them regarding the impact of the pandemic and the processes employed for the protection of research personnel and participants with respect to the conduct of research, specifically for studies unrelated to COVID-19.
In this report, we describe the results of the survey findings in the context of the current understanding of disease transmission and mitigation techniques.
We reflect on common practices and provide recommendations regarding lessons learned that will be relevant to future pandemics, particularly with regards to staging the cessation and resumption of research activities with an aim to keep the workforce, research participants, and our communities safe in future pandemics.
The COVID-19 pandemic has led to major disruptions in the clinical research enterprise. Investigators and staff at the University of Washington and Seattle Children’s Research Institute (SCRI) were surveyed to determine the impact of the pandemic restrictions on their non-COVID-19 clinical research studies. Enrollment and study visits were stopped for over half of the interventional trials. There were both positive and negative impacts of the work restrictions on the professional and personal lives of faculty and staff. Academic and research institutions should consider how best to support investigators and their teams during this pandemic.
The 2020 COVID-19 pandemic has had a profound impact on the clinical research enterprises at the 60 Clinical and Translational Science Award (CTSA) Hubs throughout the nation. There was simultaneously a need to expand research to obtain crucial data about disease prognosis and therapy and enormous limitations on conducting research as localities and institutions limited travel and person-to-person contact. These imperatives resulted in major changes in the way research was conducted, including expediting Institutional Review Board review, shifting to remote interactions with participants, centralizing decision-making in prioritizing research protocols, establishing biobanks, adopting novel informatics platforms, and distributing study drugs in unconventional ways. National CTSA Steering Committee meetings provided an opportunity to share best practices and develop the idea of capturing the CTSA program experiences in a series of papers. Here we bring together the recommendations from those papers in a list of specific actions that research sites can take to strengthen operations and prepare for similar future public health emergencies. Most importantly, creative innovations developed in response to the COVID-19 pandemic deserve serious consideration for adoption as new standards, thus converting the painful trauma of the pandemic into “post-traumatic growth” that makes the clinical research enterprise stronger, more resilient, and more effective.