About
317
Publications
29,546
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
28,611
Citations
Introduction
Skills and Expertise
Publications
Publications (317)
Background
The volume of mechanical thrombectomy (MT) performed at hospitals is used as one of the criteria for advanced-level designation for stroke care.
Objective
Our study sought to determine the relationship between annual MT procedural volume and in-hospital outcomes in acute ischemic stroke patients undergoing MT in the United States.
Meth...
Background and Purpose
Intraarterial thrombolysis as an adjunct to mechanical thrombectomy is increasingly being considered to enhance reperfusion in acute ischemic stroke patients. Intraarterial thrombolysis may increase the risk of post‐thrombectomy intracerebral hemorrhage (ICH) in certain patient subgroups.
Methods
We analyzed acute ischemic s...
BACKGROUND
People who are socioeconomically disadvantaged (SED) have high smoking rates and face barriers to participation in smoking cessation interventions. One strategy to reach and engage these individuals is by delivering computer-tailored messages via text messages. Computer-tailored health communication, which is focused on finding the most...
Background
Physician transfer is an alternate option to patient transfer for expedient performance of mechanical thrombectomy in patients with acute ischemic stroke.
Methods and Results
We conducted a systematic review to identify studies that evaluate the effect of physician transfer in patients with acute ischemic stroke who undergo mechanical t...
Importance
Chronic kidney disease (CKD) is an often-asymptomatic complication of type 2 diabetes (T2D) that requires annual screening to diagnose. Patient-level factors linked to inadequate screening and treatment can inform implementation strategies to facilitate guideline-recommended CKD care.
Objective
To identify risk factors for nonconcordanc...
OBJECTIVES/GOALS: Empowering the Participant Voice (EPV) is a 6-CTSA Rockefeller-led collaboration to developcustom REDCap infrastructure to collect participant feedback using the validated Research Participant Perception Survey (RPPS), demonstrate its value in use cases, and disseminate it for broad adoption. METHODS/STUDY POPULATION: The EPV team...
BACKGROUNDCOVID-19 convalescent plasma (CCP) virus-specific antibody levels that translate into recipient posttransfusion antibody levels sufficient to prevent disease progression are not defined.METHODS
This secondary analysis correlated donor and recipient antibody levels to hospitalization risk among unvaccinated, seronegative CCP recipients wit...
Empowering the Participant Voice (EPV) is an NCATS-funded six-CTSA collaboration to develop, demonstrate, and disseminate a low-cost infrastructure for collecting timely feedback from research participants, fostering trust, and providing data for improving clinical translational research. EPV leverages the validated Research Participant Perception...
Background: Physician transfer has been explored as an alternate option to patient transfer for the expedient performance of mechanical thrombectomy in acute ischemic stroke patients.
Methods: We conducted a systematic review to identify studies that evaluate the effect of physician transfer in patients with acute ischemic stroke who undergo mechan...
Introduction
The COVID-19 pandemic has altered the design, conduct, and dissemination of medical and scientific research; yet, little is known regarding the changes in publication trends as a result of the pandemic. The principal objective of this study was to evaluate the changes associated with the COVID-19 pandemic regarding the representation o...
Nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) are highly prevalent but underdiagnosed.
We used an electronic health record data network to test a population-level risk stratification strategy using noninvasive tests (NITs) of liver fibrosis.
Data were obtained from PCORnet® sites in the East, Midwest, Southwest, a...
In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ Clinical and Translational Science Award (CTSA) hubs across the country to support the design and cond...
Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Netwo...
Importance
Multicenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. The Trial Innovation Network (TIN), established in 2016 to partner with the Clinical and Translati...
Objectives:
This study evaluated the impact of standardized care protocols, as a part of a quality improvement initiative (XXX), on hospital readmission rates for patients with a diagnosis of congestive heart failure (CHF) and/or chronic obstructive pulmonary disease (COPD) after being discharged to skilled nursing facilities (SNFs).
Design:
A r...
Background:
COVID-19 convalescent plasma (CCP) is an important therapeutic option for outpatients at high risk of hospitalization from SARS-CoV-2 infection. We assessed the safety of outpatient CCP transfusions administered during clinical trials.
Study design and methods:
We analyzed data pertaining to transfusion-related reactions from two ran...
New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to parti...
Background
In 2018, the time window for mechanical thrombectomy eligibility in patients with acute ischemic stroke increased from within 6 hours to within 24 hours of symptom onset. The purpose of this study was to evaluate the effect of window expansion on procedural and hospital volumes and patient outcomes at a national level.
Methods
We conduc...
Importance:
Tobacco smoking drives markedly elevated cardiovascular disease risk and preventable death in persons with serious mental illness, and these risks are compounded by the high prevalence of overweight/obesity that smoking cessation can exacerbate. Guideline-concordant combined pharmacotherapy and behavioral smoking cessation treatment im...
Background:
There is conflicting evidence as to whether intra-arterial thrombolysis (IAT) adds benefit in patients with acute stroke who undergo mechanical thrombectomy (MT).
Methods:
We conducted a systematic review to identify studies that evaluate IAT in patients with acute stroke who undergo MT. Data were extracted from relevant studies foun...
One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality contr...
Background:
Although observational studies have reported favorable clinical outcomes associated with intra-arterial thrombolysis as adjunct to mechanical thrombectomy, the cost and length of hospitalization associated with this intervention has not been studied.
Methods:
We analyzed the nationally representative data of the United States data fr...
Objective:
To explore trends in blood pressure (BP) control before and during the COVID-19 pandemic.
Patients and methods:
Health systems participating in the National Patient-Centered Clinical Research Network (PCORnet) Blood Pressure Control Laboratory Surveillance System responded to data queries, producing 9 BP control metrics. Averages of t...
OBJECTIVES/GOALS: Empowering the Participant Voice (EPV) is a Rockefeller-led 6-CTSA consortium that aims to collect research participant feedback through new Research Participant Perception Survey (RPPS)/REDCap infrastructure and data aggregation to a national database. Here we describe diverse Use Cases and launch dissemination to other hubs. MET...
BACKGROUND
The COVID-19 convalescent plasma (CCP) viral specific antibody levels that translate into recipient post-transfusion antibody levels sufficient to prevent disease progression is not defined.
METHODS
This secondary analysis correlated donor and recipient antibody levels to hospitalization risk among unvaccinated, seronegative CCP recipie...
Objectives
Preventing migraine headaches and improving the quality of life for patients with migraine remains a challenge. We hypothesized intensive meditation training would reduce the disease burden of migraine.Method
An unblinded trial was analyzed as a single cohort exposed to a silent 10-day Vipassana meditation retreat that included 100 hr of...
Background:
The Trial Innovation Network (TIN) is a collaborative initiative within the National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Awards (CTSA) Program. To improve and innovate the conduct of clinical trials, it is exploring the uses of gamification to better engage the trial workforce and impro...
The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network's single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, a...
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...
Background:
Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain.
Methods:
In this multicenter, double-blind, randomized, controlled trial, we evaluated the effi...
SARS-CoV-2 accesses host cells via angiotensin-converting enzyme-2, which is also affected by commonly used angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), raising concerns that ACEI or ARB exposure may portend differential COVID-19 outcomes. In parallel cohort studies of outpatient and inpatient COVID-19-...
Background:
Despite evidence of their effectiveness, free smoking quitlines are underused. The best way to educate providers about and encourage use of quitlines is not established. We examined if electronic medical record (EMR)-integrated best practices alerts (BPAs) with or without additional provider education resulted in increased quitline ref...
BACKGROUND: The efficacy of polyclonal high titer convalescent plasma to prevent serious complications of COVID-19 in outpatients with recent onset of illness is uncertain.
METHODS: This multicenter, double-blind randomized controlled trial compared the efficacy and safety of SARS-CoV-2 high titer convalescent plasma to placebo control plasma in sy...
Background
The National Patient‐Centered Clinical Research Network Blood Pressure Control Laboratory Surveillance System was established to identify opportunities for blood pressure (BP) control improvement and to provide a mechanism for tracking improvement longitudinally.
Methods and Results
We conducted a serial cross‐sectional study with queri...
As the nation seeks to recruit and retain physician-scientists, gaps remain in understanding and addressing mitigatable challenges to the success of faculty from underrepresented minority (URM) backgrounds. The Doris Duke Charitable Foundation Fund to Retain Clinical Scientists (FRCS) program, implemented in 2015 at 10 academic medical centers in t...
Background: Insufficient support for balancing career and family responsibilities hinders retention of physician-scientists. Programs to improve retention of this important group of faculty are crucial. Understanding the experiences of program implementers is key to refining and improving program offerings.
Methods: We conducted an interpretive, de...
Background
The Coronavirus Disease 2019 (COVID-19) pandemic has had substantial global morbidity and mortality. Clinical research related to prevention, diagnosis, and treatment of COVID-19 is a top priority. Effective and efficient recruitment is challenging even without added constraints of a global pandemic. Recruitment registries offer a potent...
Introduction: The COVID-19 pandemic has required urgent scientific response to investigate the disease, its prevention and treatment and interactions with cardiovascular conditions. Consequently, a centralized workflow was needed to effectively recruit, screen and connect volunteers to COVID-19 research opportunities.
Objective: To create a central...
Background
The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy.
Methods
Using an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardio...
There is a need for multimodal strategies to keep research participants informed about study results. Our aim was to characterize preferences of genomic research participants from two institutions along four dimensions of general research result updates: content, timing, mechanism, and frequency.
Methods:
We conducted a web-based cross-sectional...
Background/aims:
Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing c...
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...
There is a need for multimodal strategies to keep research participants informed about study results. Our aim was to characterize preferences of genomic research participants from two institutions along four dimensions of general research result updates: content, timing, mechanism, and frequency. Methods: We conducted a web-based cross-sectional su...
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...
The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. International Review Board (IRB) offices developed plans to rapidly review protocols related to the COVID-19 pandemic. An...
Background
New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic “Aspirin Dosing: A Patient-Centric...
Background
It is unclear whether chronic use of immunosuppressive drugs worsens or improves the severity of coronavirus disease 2019 (COVID-19), with plausible mechanisms for both.
Methods
Retrospective cohort study in 2121 consecutive adults with acute inpatient hospital admission between 4 March and 29 August 2020 with confirmed or suspected COV...
Problem:
The Food and Drug Administration Amendments Act of 2007 (FDAAA) and the National Institutes of Health (NIH) require that many clinical trials register and report results on ClinicalTrials.gov. Noncompliance with these policies denies research participants and scientists access to potentially relevant findings and could lead to monetary pe...
Background/aims:
Electronic-based recruitment methods are increasingly utilized in clinical trials to recruit and enroll research participants. The cost-effectiveness of electronic-based methods and impact on sample generalizability is unknown. We compared recruitment yields, cost-effectiveness, and demographic characteristics across several elect...
Importance
Determining the right dosage of aspirin for the secondary prevention treatment of atherosclerotic cardiovascular disease (ASCVD) remains an unanswered and critical question.
Objective
To report the rationale and design for a randomized clinical trial to determine the optimal dosage of aspirin to be used for secondary prevention of ASCVD...
Purpose:
To determine if publications from interdisciplinary collaborations involving at least 1 Johns Hopkins University author increased between 2005 and 2015 and to compare different methods for determining the disciplinarity of research articles.
Method:
In 2017-2018, 100 peer-reviewed biomedical science articles were randomly selected from...
The US Food and Drug Administration Amendments Act of 2007 (FDAAA)¹ requires that applicable clinical trials (ACTs) submit results to ClinicalTrials.gov within 1 year of completion. ClinicalTrials.gov identifies trials that likely meet this definition as probable ACTs (pACTs). A complementary National Institutes of Health (NIH) policy requires that...
Background/aim
Cost-efficient methods are essential for successful participant recruitment in clinical trials. Patient portal messages are an emerging means of recruiting potentially eligible patients into trials. We assessed the response rate and complaint rate from direct-to-patient, targeted recruitment through patient portals of an electronic m...
Objective:
The study sought to characterize institution-wide participation in secure messaging (SM) at a large academic health network, describe our experience with electronic medical record (EMR)-based cohort selection, and discuss the potential roles of SM for research recruitment.
Materials and methods:
Study teams defined eligibility criteri...
Objectives
Women report higher atrial fibrillation (AF) symptom severity and receive less AF therapies than their male counterparts. It is understudied if differences in AF therapies received explains sex differences in AF symptom severity. We investigate the impact of sex and AF therapies on patient-reported outcomes.
Methods
Participants were re...
Background
In atrial fibrillation (AF), there are known sex and sociodemographic disparities in clinical outcomes such as stroke. We investigate whether disparities also exist with respect to patient-reported outcomes. We explored the association of sex, age, and education level with patient-reported outcomes (AF-related quality of life, symptom se...
Introduction
Global data sharing is essential. This is the premise of the Academic Research Organization (ARO) Council, which was initiated in Japan in 2013 and has since been expanding throughout Asia and into Europe and the United States. The volume of data is growing exponentially, providing not only challenges but also the clear opportunity to...
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...
Background: Including stakeholders in the process and outcomes of comparative effectiveness research (CER) can help ensure that research questions are relevant and findings are communicated to individuals who need them for decision-making. Yet limited strategies are available to assist researchers with stakeholder engagement.While health system lea...
OBJECTIVES/SPECIFIC AIMS: The objectives of this study were to compare different methods for determining the disciplines involved in a research article. We sought to address the following questions: To what extent does the number of disciplines reported by an article’s corresponding author agree with their description of the article as unidisciplin...
Introduction
We developed a service to identify potential study participants through electronic medical records and deliver study invitations through patient portals.
Methods
The service was piloted in a cohort study that used multiple recruitment methods.
Results
Patient portal messages were sent to 1303 individuals and the enrollment rate was 1...
Background:
Many clinical trials conducted by academic organizations are not published, or are not published completely. Following the US Food and Drug Administration Amendments Act of 2007, "The Final Rule" (compliance date April 18, 2017) and a National Institutes of Health policy clarified and expanded trial registration and results reporting r...
Background
Academic health systems and their investigators are challenged to systematically assure clinical research regulatory compliance. This challenge is heightened in the emerging era of centralized single Institutional Review Boards for multicenter studies, which rely on monitoring programs at each participating site.
Objective
To describe t...
OBJECTIVES/SPECIFIC AIMS: The purpose of this study is to determine if the prevalence of interdisciplinary collaborations has increased over the past 10 years at 1 CTSA-funded institution. METHODS/STUDY POPULATION: We used Scopus to identify all articles published by authors affiliated with any of the Johns Hopkins Institutions for the years 2005,...
