Paul A Harris

Paul A Harris
Vanderbilt University | Vander Bilt · Department of Biomedical Informatics

About

118
Publications
15,314
Reads
How we measure 'reads'
A 'read' is counted each time someone views a publication summary (such as the title, abstract, and list of authors), clicks on a figure, or views or downloads the full-text. Learn more
32,531
Citations
Citations since 2016
35 Research Items
26739 Citations
201620172018201920202021202201,0002,0003,0004,0005,0006,000
201620172018201920202021202201,0002,0003,0004,0005,0006,000
201620172018201920202021202201,0002,0003,0004,0005,0006,000
201620172018201920202021202201,0002,0003,0004,0005,0006,000
Additional affiliations
January 1997 - present
Vanderbilt University

Publications

Publications (118)
Article
Full-text available
Background Previous studies support cultural tailoring of recruitment materials as a strategy to promote the enrollment of minoritized groups in clinical trials. However, there is a lack of guidance for research teams to create culturally tailored materials, potentially contributing to low recruitment rates of minoritized groups. We describe the de...
Article
Importance: Effective methods for engaging clinicians in continuing education for learning-based practice improvement remain unknown. Objective: To determine whether a smartphone-based app using spaced education with retrieval practice is an effective method to increase evidence-based practice. Design, setting, and participants: A prospective,...
Article
Full-text available
The Recruitment Innovation Center (RIC) has created a toolkit of novel strategies to engage potential participants in response to recruitment and retention challenges associated with COVID-19 studies. The toolkit contains pragmatic, generalizable resources to help research teams increase awareness of clinical trials and opportunities to participate...
Article
Objectives The HL7® fast healthcare interoperability resources (FHIR®) specification has emerged as the leading interoperability standard for the exchange of healthcare data. We conducted a scoping review to identify trends and gaps in the use of FHIR for clinical research. Materials and methods We reviewed published literature, federally funded p...
Article
Full-text available
Opioid misuse is at a crisis level. In response to this epidemic, the National Institutes of Health has funded $945 million in research through the Helping to End Addiction Long-term (HEAL) Pain Management Initiative, including funding to the Vanderbilt Recruitment Innovation Center (RIC) to strategize methods to catalyze participant recruitment. T...
Article
Full-text available
Importance: Awake prone positioning may improve hypoxemia among patients with COVID-19, but whether it is associated with improved clinical outcomes remains unknown. Objective: To determine whether the recommendation of awake prone positioning is associated with improved outcomes among patients with COVID-19-related hypoxemia who have not receiv...
Article
Full-text available
This paper provides a description of the MyCap data collection platform, utilization metrics, and vignettes associated with use from diverse research institutions. MyCap is a participant-facing mobile application for survey data collection and the automated administration of active tasks (activities performed by participants using mobile device sen...
Article
Full-text available
OBJECTIVES/GOALS: Six CTSA sites formed a collaboration to DEVELOP, DEMONSTRATE, AND DISSEMINATE new infrastructure to streamline collection and analysis of research participant feedback, using the Research Participant Perception Survey (RPPS), common standards, and customized REDCap-based tools, to improve the clinical research enterprise. METHODS...
Article
Full-text available
For decades, the research community called for streamlined Institutional Review Board (IRB) review processes for multisite studies. Department of Health and Human Services and National Institutes of Health (NIH) recognized this need and implemented single IRB (sIRB) of record mandates. However, announcing mandates without sufficient operational gui...
Article
Full-text available
Introduction: The process of identifying and connecting with clinical trial study teams can be challenging and difficult for members of the public. The national volunteer community registry, ResearchMatch, and the public clinical trials search tool, Trials Today, work in tandem to bridge this connection by providing a streamlined process for poten...
Conference Paper
INTRODUCTION Under-representation in health-related research is one of a multitude of factors that contribute to cancer disparities experienced by African American and Latinx communities. Barriers to research participation stem from historical social injustices, are multi-faceted and include factors specific to the research process, research team m...
Article
Full-text available
Objective The Recruitment Innovation Center (RIC), partnering with the Trial Innovation Network and institutions in the National Institutes of Health-sponsored Clinical and Translational Science Awards (CTSA) Program, aimed to develop a service line to retrieve study population estimates from electronic health record (EHR) systems for use in select...
Article
Background Financial incentives may aid recruitment to clinical trials, but evidence regarding risk/burden-driven variability in participant preferences for incentives is limited. We developed and tested a framework to support real-world decisions on recruitment budget. Methods We included two phases: an Anchoring Survey, to ensure we could captur...
Article
Full-text available
Clinical trials continue to face significant challenges in participant recruitment and retention. The Recruitment Innovation Center (RIC), part of the Trial Innovation Network (TIN), has been funded by the National Center for Advancing Translational Sciences of the National Institutes of Health to develop innovative strategies and technologies to e...
Article
Full-text available
Objectives To share our approach for designing, developing, and deploying the Research Electronic Data Capture (REDCap) Mobile Application, details about its dissemination and support through the REDCap Consortium, and a set of lessons learned and guidance recommendations for others developing mobile platforms to support research in regions or situ...
Article
Full-text available
Introduction The use of online platforms for pediatric healthcare research is timely, given the current pandemic. These platforms facilitate trial efficiency integration including electronic consent, randomization, collection of patient/family survey data, delivery of an intervention, and basic data analysis. Methods We created an online digital p...
Article
Full-text available
Introduction Barriers to research participation by racial and ethnic minority group members are multi-factorial, stem from historical social injustices and occur at participant, research team, and research process levels. The informed consent procedure is a key component of the research process and represents an opportunity to address these barrier...
Article
Introduction: Social media, including Facebook outreach, is increasingly being used as a participant recruitment tool, and may be particularly useful in tobacco and smoking cessation studies. The Recruitment Innovation Center at Vanderbilt University Medical Center partnered with Project LUNA, a smoking cessation study, to conduct a pilot social m...
Article
Full-text available
Introduction The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an established clinical research network that pivoted to respond to the pandemic. Methods The TIN’s three Trial Inn...
Article
Full-text available
Background Racial and ethnic minorities are often underrepresented in clinical trials, threatening the generalizability of trial results. Several factors may contribute to underrepresentation of minorities in clinical trials, including lack of training for researchers and staff on the importance of diversity in clinical trials and effective strateg...
Article
Full-text available
The COVID-19 pandemic has resulted in an unprecedented strain on every aspect of the healthcare system, and clinical research is no exception. Researchers are working against the clock to ramp up research studies addressing every angle of COVID-19 – gaining a better understanding of person-to-person transmission, improving methods for diagnosis, an...
Article
Full-text available
Introduction: Clinical trial participation among US Hispanics remains low, despite a significant effort by research institutions nationwide. ResearchMatch, a national online platform, has matched 113,372 individuals interested in participating in research with studies conducted by 8778 researchers. To increase accessibility to Spanish speakers, we...
Article
Full-text available
OBJECTIVES/GOALS: Innovations with positive health impact are a high priority for NCATS and CTSAs. Program design that uses the Causal Pathway approach incorporates performance indicators that assess impact. We applied Causal Pathway thinking to an ongoing national program to enhance the evaluation of program impact. We report Lessons Learned. METH...
Article
Full-text available
Equipoise and research in the current COVID-19 pandemic - Jill M. Pulley, Rebecca N. Jerome, Todd W. Rice, Christopher J. Lindsell, Paul A. Harris, Terri L. Edwards, Consuelo H. Wilkins, Gordon R. Bernard
Article
Full-text available
Introduction The updated common rule, for human subjects research, requires that consents “begin with a ‘concise and focused’ presentation of the key information that will most likely help someone make a decision about whether to participate in a study” (Menikoff, Kaneshiro, Pritchard. The New England Journal of Medicine . 2017; 376 (7): 613–615.)....
Article
Full-text available
Background Finding the optimal treatment for a chronic condition can be a complex and lengthy endeavor for both the patient and the clinician. To address this challenge, we developed an “N-of-1” quality improvement infrastructure to aid providers and patients in personalized treatment decision-making using systematic assessment of patient-reported...
Article
Drug repurposing is the application of approved drugs to treat diseases separate and distinct from their original indications. Herein, we define the scope of all practical precision drug repurposing using DrugBank, a publicly available database of pharmacological agents, and BioVU, a large, de-identified DNA repository linked to longitudinal electr...
Article
Full-text available
Introduction Research opportunities associated with the proliferation of the electronic health record (EHR), big data initiatives, and innovative approaches to trial design can present challenges for obtaining and documenting informed consent. Broad-scale informed consent (a term used herein to describe institutional models, rather than the Common...
Article
Full-text available
Introduction Individuals experiencing different medical conditions, as well as healthy volunteers, may often be interested in trial participation, and researchers similarly need to find participants to advance medical knowledge. The ResearchMatch Trials Today clinical trial searching tool leverages clinicaltrials.gov data to enable potential partic...
Article
There is growing public demand that research participants receive all of their results, regardless of whether clinical action is indicated. Instead of the standard practice of returning only actionable results, we propose a reconceptualization called "return of value" to encompass the varied ways in which research participants value specific result...
Article
Full-text available
Background To identify potential participants for clinical trials, electronic health records (EHRs) are searched at potential sites. As an alternative, we investigated using medical devices used for real-time diagnostic decisions for trial enrollment. Methods To project cohorts for a trial in acute coronary syndromes (ACS), we used electrocardiogr...
Article
Full-text available
Potential participants seek information about clinical trials for many reasons, but the process can be challenging. We analyzed 101,249 searches in ResearchMatch Trials Today, a free interface to recruiting trials from ClinicalTrials.gov. Searches from March 2015 to November 2016 included a broad range of conditions and healthy volunteer concepts,...
Article
Full-text available
Inefficiencies in the national clinical research infrastructure have been apparent for decades. The National Center for Advancing Translational Science—sponsored Clinical and Translational Science Award (CTSA) program is able to address such inefficiencies. The Trial Innovation Network (TIN) is a collaborative initiative with the CTSA program and o...
Article
Objective Health care generated data have become an important source for clinical and genomic research. Often, investigators create and iteratively refine phenotype algorithms to achieve high positive predictive values (PPVs) or sensitivity, thereby identifying valid cases and controls. These algorithms achieve the greatest utility when validated a...
Article
Background and objective: There is an increasing desire to share de-identified electronic health records (EHRs) for secondary uses, but there are concerns that clinical terms can be exploited to compromise patient identities. Anonymization algorithms mitigate such threats while enabling novel discoveries, but their evaluation has been limited to s...
Article
When clinical trial enrollment is not an option for seriously ill patients whose illnesses have not responded to approved treatment options, those patients and their physicians may consider gaining access to investigational therapies through a pathway established by the Food and Drug Administration (FDA) called expanded access. However, recent even...
Article
Full-text available
Background: Electronic health records (EHRs) are increasingly used for clinical and translational research through the creation of phenotype algorithms. Currently, phenotype algorithms are most commonly represented as noncomputable descriptive documents and knowledge artifacts that detail the protocols for querying diagnoses, symptoms, procedures,...
Article
Peer-reviewed publications are one measure of scientific productivity. From a project, program, or institutional perspective, publication tracking provides the quantitative data necessary to guide the prudent stewardship of federal, foundation, and institutional investments by identifying the scientific return for the types of support provided. In...
Article
Background: Although research participation is essential for clinical investigation, few quantitative outcome measures exist to assess participants' experiences. To address this, we developed and deployed a survey at 15 NIH-supported clinical research centers to assess participant-centered outcomes; we report responses from 4,961 participants. Me...
Article
Full-text available
The Mid-South Clinical Data Research Network (CDRN) encompasses three large health systems: (1) Vanderbilt Health System (VU) with electronic medical records for over 2 million patients, (2) the Vanderbilt Healthcare Affiliated Network (VHAN) which currently includes over 40 hospitals, hundreds of ambulatory practices, and over 3 million patients i...
Article
The last decade has seen an exponential growth in the quantity of clinical data collected nationwide, triggering an increase in opportunities to reuse the data for biomedical research. The Vanderbilt research data warehouse framework consists of identified and de-identified clinical data repositories, fee-for-service custom services, and tools buil...
Article
Full-text available
The 61 CTSA Consortium sites are home to valuable programs and infrastructure supporting translational science and all are charged with ensuring that such investments translate quickly to improved clinical care. Catalog of Assets for Translational and Clinical Health Research (CATCHR) is the Consortium's effort to collect and make available informa...
Article
REDCap (Research Electronic Data Capture) is a web-based software solution and tool set that allows biomedical researchers to create secure online forms for data capture, management and analysis with minimal effort and training. The Shared Data Instrument Library (SDIL) is a relatively new component of REDCap that allows sharing of commonly used da...
Article
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health convened a working group in June 2011 to examine alternative institutional review board (IRB) models. The working group was held in response to proposed changes in the regulations for government-supported research and the proliferation of multicenter clinical...
Article
A set of principles is proposed for sponsors and developers of research computing applications that can increase the likelihood of successful adoption by researchers.
Article
Information technology (IT) to support clinical research has steadily grown over the past 10 years. Many new applications at the enterprise level are available to assist with the numerous tasks necessary in performing clinical research. However, it is not clear how rapidly this technology is being adopted or whether it is making an impact upon how...
Article
The authors designed ResearchMatch, a disease-neutral, Web-based recruitment registry to help match individuals who wish to participate in clinical research studies with researchers actively searching for volunteers throughout the United States. In this article, they describe ResearchMatch's stakeholders, workflow model, technical infrastructure, a...
Article
StarBRITE is a one-stop, web-based research portal designed to meet the day-to-day needs of the Vanderbilt University and Meharry Medical College research community during the planning and conduct of research studies. StarBRITE serves as the main online location for research support addressing issues such as identification and location of resources...
Article
Information necessary to recognize unexpected drug efficacy is not routinely collected. Once a drug is approved, opportunities for understanding these phenomena are usually lost within clinical care. We propose that patients are willing to provide a wide range of experiential knowledge about the effects of therapies that is seldom solicited. Experi...
Article
Vascular alpha2B-adrenergic receptors (alpha2B-ARs) mediate vasoconstriction and contribute to peripheral regulation of vascular tone. In vitro, a common 301-303 deletion in the alpha2B-AR gene, ADRA2B, results in loss of alpha2B-AR desensitization. We examined the hypothesis that ADRA2B del301-303 or other common ADRA2B variants alter vascular des...
Article
The regulatory review and approval process is a significant part of the workflow associated with initiating clinical and translational research projects. Ambiguity concerning submission requirements and expected times associated with the review process can create additional work for research teams and ultimately delay important scientific projects....
Article
Full-text available
Objectives Cold-induced vasoconstriction is mediated in part by selective enhancement of local α2C-adrenoceptor (α2C-AR) activity. A common insertion–deletion variant in the α2C-AR gene (ADRA2C del322–325) results in an approximately 85% reduction of agonist-mediated function in vitro. We tested the hypothesis that individuals with the ADRA2C del32...
Article
Clinical and translational research increasingly requires computation. Projects may involve multiple computationally oriented groups including information technology (IT) professionals, computer scientists, and biomedical informaticians. However, many biomedical researchers are not aware of the distinctions among these complementary groups, leading...
Article
The mechanisms underlying interindividual variability in pain perception and cognitive responses are undefined but highly heritable. alpha(2C)- and alpha(2A)-adrenergic receptors regulate noradrenergic activity and are important mediators of pain perception and analgesia. We hypothesized that common genetic variants in these genes, particularly the...
Article
Black patients may be less responsive to beta-blockers than whites. Genetic variants in the beta1-adrenergic receptor (beta1-AR) associated with lesser response to beta-blockers are more common in blacks than in whites. The purpose of this study was to determine whether ethnic differences in response to beta-blockade can be explained by differing d...
Article
Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use o...
Article
QT interval for a given heart rate differs between exercise and recovery (QT hysteresis) due to slow QT adaptation to changes in heart rate. We hypothesized that QT hysteresis is evident within stages of exercise and investigated which component of the QT contributes to hysteresis. Nineteen healthy volunteers performed a staged exercise test (four...
Article
Previous studies of patients with postural tachycardia syndrome (POTS) have been hampered by relatively small cohorts, failure to control medications and diet, and inconsistent testing procedures. The Vanderbilt Autonomic Dysfunction Center Database provided results of posture studies performed in 165 patients and 66 normal controls after dietary a...