Background Accurate, timely ascertainment of clinical end points, particularly hospitalizations, ... more Background Accurate, timely ascertainment of clinical end points, particularly hospitalizations, is crucial for clinical trials. The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study extended the main TAILOR-PCI trial's follow-up to 2 years, using a smartphone-based research app featuring geofencing-triggered surveys and routine monthly mobile phone surveys to detect cardiovascular (CV) hospitalizations. This pilot study compared these digital tools to conventional site-coordinator ascertainment of CV hospitalizations. Objective The objectives were to evaluate geofencing-triggered notifications and routine monthly mobile phone surveys' performance in detecting CV hospitalizations compared to telephone visits and health record reviews by study coordinators at each site. Methods US and Canadian participants from the TAILOR-PCI Digital Follow-Up Study were invited to down...
Background: As reported previously, 140 methamphetamine-dependent participants at eight medical c... more Background: As reported previously, 140 methamphetamine-dependent participants at eight medical centers in the U.S. were assigned randomly to receive topiramate (N = 69) or placebo (N = 71) in a 13week clinical trial. The study found that topiramate did not appear to reduce methamphetamine use significantly for the primary outcome (i.e., weekly abstinence from methamphetamine in weeks 6-12). Given that the treatment responses varied considerably among subjects, the objective of this study was to identify the heterogeneous treatment effect of topiramate and determine whether topiramate could reduce methamphetamine use effectively in a subgroup of subjects. Methods: Latent variable analysis was used for the primary and secondary outcomes during weeks 6-12 and 1-12, adjusting for age, sex, and ethnicity. Results: Our analysis of the primary outcome identified 30 subjects as responders, who either reduced methamphetamine use consistently over time or achieved abstinence. Moreover, topiramate recipients had a significantly steeper slope in methamphetamine reduction and accelerated to abstinence faster than placebo recipients. For the secondary outcomes in weeks 6-12, we identified 40 subjects as responders (who had significant reductions in methamphetamine use) and 65 as non-responders; topiramate recipients were more than twice as likely as placebo recipients to be responders (odds ratio = 2.67; p = 0.019). Separate analyses of the outcomes during weeks 1-12 yielded similar results. Conclusions: Methamphetamine users appear to respond to topiramate treatment differentially. Our findings show an effect of topiramate on the increasing trend of abstinence from methamphetamine, suggesting that a tailored intervention strategy is needed for treating methamphetamine addiction.
The aging population is growing faster in the correctional system than in the overall U.S. popula... more The aging population is growing faster in the correctional system than in the overall U.S. population. Yet, an effective geriatric transitional care process is not available for older persons released from jail. This article documents the development and results of an evidence-based, adaptive transitional care tool guided by Meleis’ transitions theory to improve access to medications for older persons released from jail. Three sources of evidence were used to develop the tool: different categories of literature, expert panel determination of the tool’s domain and content relevance and importance, and a focus group interview of five people working in a transitions clinic. More research is required to validate the tool in the field
Executive Summary As baby boomers age, the nation’s elderly population continues to grow. A major... more Executive Summary As baby boomers age, the nation’s elderly population continues to grow. A majority of these individuals will continue to live in their own home. Meeting this societal need requires a new generation of research that addresses the complexity of supporting the quality of life and independence of a vast, diverse and aging population. New technologies could potentially allow older adults and people with disabilities to remain in their homes longer, reduce health care costs, enhance their quality of life, and provide needed support to independent caregivers.
Despite a growing aging population in the correctional system, older persons are often released f... more Despite a growing aging population in the correctional system, older persons are often released from jail unprepared for the transition to the free world and unable to access necessary medications. This article proposes a discharge form (transitional care tool) that may improve the medical care provided to older inmates upon release from jail, especially regarding their compliance with prescribed medications. The authors developed their tool in a three-step process: (1) review concerns raised in pertinent correctional medical literature, (2) expert panel determination of the relative importance for each of the concerns, and (3) assessment of the tool's likely efficacy as viewed by a focus group familiar with transitions to the free world after incarceration. Further research is required to validate the tool in the field.
Background/Introduction TAILOR-PCI is the largest cardiovascular genotype-based randomized trial ... more Background/Introduction TAILOR-PCI is the largest cardiovascular genotype-based randomized trial (NCT#01742117) investigating whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes after percutaneous coronary intervention (PCI). The TAILOR-PCI Digital Sub-Study tests the feasibility of extending original follow-up of 1 year to 2 years using state-of-the-art digital solutions. Deep phenotyping acquired during a clinical trial can be leveraged by extending follow-up in an efficient and cost-effective manner using digital technology. Purpose Our objective is to describe onboarding and engagement of participants initially recruited in a large, pragmatic, international, multi-center clinical trial to a digital registry. Methods TAILOR-PCI participants, within 23 months of their index PCI, were invited by letters containing a URL to the Digital Sub-Study website (http://tailorpci.eurekaplatform.org). These invitations were followed by phone calls, if ...
In order to evaluate the current standard of care for the management of respiratory failure in pa... more In order to evaluate the current standard of care for the management of respiratory failure in patients with amyotrophic lateral sclerosis (ALS), a questionaire was mailed to the Medical Directors of 48 multidisciplinary ALS centers in the United States. Twenty centers reported information on 2357 patients, mean of 124 patients per center. Pulmonary function tests were performed at each visit in 17 / 20 institutions. Arterial blood gases, maximal expiratory pressures and maximal inspiratory pressures were followed in three centers and serum chloride was monitored in only four centers. The use of non-invasive ventilation (NIV) was extremely variable (range 0-50%) and included 360 patients (15%). The majority of centers used symptoms / signs of hypoventilation and worsening forced vital capacity (FVC) to initiate NIV with no established protocol. A FVC between 20 and 40% was used by most centers to initiate NIV. Due to great variability in the approach to monitoring pulmonary function among ALS centers and the modest effects of current medications to slow disease progression, we propose the use of a structured protocol which can prospectively study the role of NIV in prolonging survival and improving quality of life.
Myasthenia gravis (MG) is an antigen-specific autoimmune disease caused by antibodies against ace... more Myasthenia gravis (MG) is an antigen-specific autoimmune disease caused by antibodies against acetylcholine receptors (AChR) at the post-synaptic membrane of the neuromuscular junction. Clinical and immunological data imply the involvement of AChR-specific T lymphocytes as helper cells for autoantibody production. Direct data to support this hypothesis, however, remain sparse. In the present study, a large population of MG patients was studied for evidence of peripheral blood T cell activation by several assays. Assays based on non-specific measurements of T cell activation as well as assays of antigen-specific clonal expansion were utilized. Levels of soluble IL-2 receptor in serum were modestly elevated in some patients, suggesting T cell activation. However, peripheral blood cells did not show evidence of IL-2 receptor expression or enhanced reactivity to IL-2 in culture. Clonable T cells selected for hypoxanthine phosphoribosyl transferase (hprt) mutation, another non-antigen-specific marker for T cell activation, were not seen with increased frequency except in patients treated with purine analogs. Antigen-specific T cell activation was measured by proliferation assays using heterologous and autologous sources of AChR. Antigen-restimulated peripheral blood cell cultures were cloned by limiting dilution. The vast majority of patients failed to show convincing evidence of AChR specific T cell activation or clonal expansion; only 2 of 44 patients demonstrated clonable autologous AChR-specific T cells. An alternative hypothesis of T cell involvement in MG is proposed in which T cell activation is discontinuous and predominantly directed at antigens other than AChR.
Journal of the American College of Cardiology, Jan 20, 2017
Currently, 2.2 million individuals are incarcerated, and more than 11 million have been released ... more Currently, 2.2 million individuals are incarcerated, and more than 11 million have been released from U.S. correctional facilities. Individuals with a history of incarceration are more likely to be of racial and ethnic minority populations, poor, and have higher rates of cardiovascular risk factors, especially smoking and hypertension. Cardiovascular disease is a leading cause of death among incarcerated individuals, and those recently released have a higher risk of being hospitalized and dying of cardiovascular disease compared with the general population, even after accounting for differences in racial identity and socioeconomic status. In this review, the authors: 1) present information on the cardiovascular health of justice-involved populations, and unique prevention and care conditions in correctional facilities; 2) identify knowledge gaps; and 3) propose promising areas for research to improve the cardiovascular health of this population. An Executive Summary of a National He...
free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource... more free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre-including this research content-immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and ... more Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and medical devices and other health system interventions. The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health system interventions. The concept of a “digital clinical trial” involves leveraging digital technology to improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation, and has the potential to transform clinical trials and to lower their cost. In April 2019, the US National Institutes of Health (NIH) and the National Science Foundation (NSF) held a workshop bringing together experts in clinical trials, digital technology, and digital analytics to discuss strategies to implement the use of digital technologies in clinical trials while considering potential challenges. This position paper builds on this workshop to describ...
Point-of-care technologies (POC or POCT) are enabling innovative cardiovascular diagnostics that ... more Point-of-care technologies (POC or POCT) are enabling innovative cardiovascular diagnostics that promise to improve patient care across diverse clinical settings. The National Heart, Lung, and Blood Institute convened a working group to discuss POCT in cardiovascular medicine. The multidisciplinary working group, which included clinicians, scientists, engineers, device manufacturers, regulatory officials, and program staff, reviewed the state of the POCT field; discussed opportunities for POCT to improve cardiovascular care, realize the promise of precision medicine, and advance the clinical research enterprise; and identified barriers facing translation and integration of POCT with existing clinical systems. A POCT development roadmap emerged to guide multidisciplinary teams of biomarker scientists, technologists, health care providers, and clinical trialists as they: 1) formulate needs assessments; 2) define device design specifications; 3) develop component technologies and integrated systems; 4) perform iterative pilot testing; and 5) conduct rigorous prospective clinical testing to ensure that POCT solutions have substantial effects on cardiovascular care.
BACKGROUND The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel R... more BACKGROUND The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study is a novel proof-of-concept study that evaluated the feasibility of extending the TAILOR-PCI randomized controlled trial (RCT) follow-up period by using a remote digital platform. OBJECTIVE The aim of this study is to describe patients’ onboarding, engagement, and results in a digital study after enrollment in an RCT. METHODS In this intervention study, previously enrolled TAILOR-PCI patients in the United States and Canada within 24 months of randomization were invited by letter to download the study app. Those who did not respond to the letter were contacted by phone to survey the reasons for nonparticipation. A direct-to-patient digital research platform (the Eureka Research Platform) was used to onboard patients, obtain consent, and administer activities in the digital study. The patients were asked to comple...
Aim-Modafinil was tested for efficacy in decreasing use in methamphetamine-dependent participants... more Aim-Modafinil was tested for efficacy in decreasing use in methamphetamine-dependent participants, compared to placebo. Methods-This was a randomized, double-blind, placebo-controlled study, with 12 weeks of treatment and a 4-week follow-up. Eight outpatient substance abuse treatment clinics participated
Aims-Topiramate has shown efficacy at facilitating abstinence from alcohol and cocaine abuse. Thi... more Aims-Topiramate has shown efficacy at facilitating abstinence from alcohol and cocaine abuse. This double-blind, placebo-controlled outpatient trial tested topiramate for treating methamphetamine addiction. Design-Participants (N=140) were randomized to receive topiramate or placebo (13 weeks) in escalating doses from 50 mg/day to the target maintenance of 200 mg/day in weeks 6-12 (tapered in week 13). Medication was combined with weekly brief behavioral compliance enhancement treatment. Setting-The trial was conducted at eight medical centers in the United States. Participants-One hundred forty methamphetamine-dependent adults took part in the trial. Measurements-The primary outcome was abstinence from methamphetamine during weeks 6-12. Secondary outcomes included use reduction versus baseline, as well as psychosocial variables.
IEEE Journal of Translational Engineering in Health and Medicine, 2016
The commercialization of new point of care technologies holds great potential in facilitating and... more The commercialization of new point of care technologies holds great potential in facilitating and advancing precision medicine in heart, lung, blood, and sleep (HLBS) disorders. The delivery of individually tailored health care to a patient depends on how well that patient's health condition can be interrogated and monitored. Point of care technologies may enable access to rapid and cost-effective interrogation of a patient's health condition in near real time. Currently, physiological data are largely limited to single-time-point collection at the hospital or clinic, whereas critical information on some conditions must be collected in the home, when symptoms occur, or at regular intervals over time. A variety of HLBS disorders are highly dependent on transient variables, such as patient activity level, environment, time of day, and so on. Consequently, the National Heart Lung and Blood Institute sponsored a request for applications to support the development and commercialization of novel point-of-care technologies through small businesses (RFA-HL-14-011 and RFA-HL-14-017). Three of the supported research projects are described to highlight particular point-of-care needs for HLBS disorders and the breadth of emerging technologies. While significant obstacles remain to the commercialization of such technologies, these advancements will be required to achieve precision medicine. INDEX TERMS Biosensor, commercialization, point-of-care technologies, precision medicine.
Aim-Modafinil was tested for efficacy in decreasing use in methamphetamine-dependent participants... more Aim-Modafinil was tested for efficacy in decreasing use in methamphetamine-dependent participants, compared to placebo.
Background Accurate, timely ascertainment of clinical end points, particularly hospitalizations, ... more Background Accurate, timely ascertainment of clinical end points, particularly hospitalizations, is crucial for clinical trials. The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study extended the main TAILOR-PCI trial's follow-up to 2 years, using a smartphone-based research app featuring geofencing-triggered surveys and routine monthly mobile phone surveys to detect cardiovascular (CV) hospitalizations. This pilot study compared these digital tools to conventional site-coordinator ascertainment of CV hospitalizations. Objective The objectives were to evaluate geofencing-triggered notifications and routine monthly mobile phone surveys' performance in detecting CV hospitalizations compared to telephone visits and health record reviews by study coordinators at each site. Methods US and Canadian participants from the TAILOR-PCI Digital Follow-Up Study were invited to down...
Background: As reported previously, 140 methamphetamine-dependent participants at eight medical c... more Background: As reported previously, 140 methamphetamine-dependent participants at eight medical centers in the U.S. were assigned randomly to receive topiramate (N = 69) or placebo (N = 71) in a 13week clinical trial. The study found that topiramate did not appear to reduce methamphetamine use significantly for the primary outcome (i.e., weekly abstinence from methamphetamine in weeks 6-12). Given that the treatment responses varied considerably among subjects, the objective of this study was to identify the heterogeneous treatment effect of topiramate and determine whether topiramate could reduce methamphetamine use effectively in a subgroup of subjects. Methods: Latent variable analysis was used for the primary and secondary outcomes during weeks 6-12 and 1-12, adjusting for age, sex, and ethnicity. Results: Our analysis of the primary outcome identified 30 subjects as responders, who either reduced methamphetamine use consistently over time or achieved abstinence. Moreover, topiramate recipients had a significantly steeper slope in methamphetamine reduction and accelerated to abstinence faster than placebo recipients. For the secondary outcomes in weeks 6-12, we identified 40 subjects as responders (who had significant reductions in methamphetamine use) and 65 as non-responders; topiramate recipients were more than twice as likely as placebo recipients to be responders (odds ratio = 2.67; p = 0.019). Separate analyses of the outcomes during weeks 1-12 yielded similar results. Conclusions: Methamphetamine users appear to respond to topiramate treatment differentially. Our findings show an effect of topiramate on the increasing trend of abstinence from methamphetamine, suggesting that a tailored intervention strategy is needed for treating methamphetamine addiction.
The aging population is growing faster in the correctional system than in the overall U.S. popula... more The aging population is growing faster in the correctional system than in the overall U.S. population. Yet, an effective geriatric transitional care process is not available for older persons released from jail. This article documents the development and results of an evidence-based, adaptive transitional care tool guided by Meleis’ transitions theory to improve access to medications for older persons released from jail. Three sources of evidence were used to develop the tool: different categories of literature, expert panel determination of the tool’s domain and content relevance and importance, and a focus group interview of five people working in a transitions clinic. More research is required to validate the tool in the field
Executive Summary As baby boomers age, the nation’s elderly population continues to grow. A major... more Executive Summary As baby boomers age, the nation’s elderly population continues to grow. A majority of these individuals will continue to live in their own home. Meeting this societal need requires a new generation of research that addresses the complexity of supporting the quality of life and independence of a vast, diverse and aging population. New technologies could potentially allow older adults and people with disabilities to remain in their homes longer, reduce health care costs, enhance their quality of life, and provide needed support to independent caregivers.
Despite a growing aging population in the correctional system, older persons are often released f... more Despite a growing aging population in the correctional system, older persons are often released from jail unprepared for the transition to the free world and unable to access necessary medications. This article proposes a discharge form (transitional care tool) that may improve the medical care provided to older inmates upon release from jail, especially regarding their compliance with prescribed medications. The authors developed their tool in a three-step process: (1) review concerns raised in pertinent correctional medical literature, (2) expert panel determination of the relative importance for each of the concerns, and (3) assessment of the tool's likely efficacy as viewed by a focus group familiar with transitions to the free world after incarceration. Further research is required to validate the tool in the field.
Background/Introduction TAILOR-PCI is the largest cardiovascular genotype-based randomized trial ... more Background/Introduction TAILOR-PCI is the largest cardiovascular genotype-based randomized trial (NCT#01742117) investigating whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes after percutaneous coronary intervention (PCI). The TAILOR-PCI Digital Sub-Study tests the feasibility of extending original follow-up of 1 year to 2 years using state-of-the-art digital solutions. Deep phenotyping acquired during a clinical trial can be leveraged by extending follow-up in an efficient and cost-effective manner using digital technology. Purpose Our objective is to describe onboarding and engagement of participants initially recruited in a large, pragmatic, international, multi-center clinical trial to a digital registry. Methods TAILOR-PCI participants, within 23 months of their index PCI, were invited by letters containing a URL to the Digital Sub-Study website (http://tailorpci.eurekaplatform.org). These invitations were followed by phone calls, if ...
In order to evaluate the current standard of care for the management of respiratory failure in pa... more In order to evaluate the current standard of care for the management of respiratory failure in patients with amyotrophic lateral sclerosis (ALS), a questionaire was mailed to the Medical Directors of 48 multidisciplinary ALS centers in the United States. Twenty centers reported information on 2357 patients, mean of 124 patients per center. Pulmonary function tests were performed at each visit in 17 / 20 institutions. Arterial blood gases, maximal expiratory pressures and maximal inspiratory pressures were followed in three centers and serum chloride was monitored in only four centers. The use of non-invasive ventilation (NIV) was extremely variable (range 0-50%) and included 360 patients (15%). The majority of centers used symptoms / signs of hypoventilation and worsening forced vital capacity (FVC) to initiate NIV with no established protocol. A FVC between 20 and 40% was used by most centers to initiate NIV. Due to great variability in the approach to monitoring pulmonary function among ALS centers and the modest effects of current medications to slow disease progression, we propose the use of a structured protocol which can prospectively study the role of NIV in prolonging survival and improving quality of life.
Myasthenia gravis (MG) is an antigen-specific autoimmune disease caused by antibodies against ace... more Myasthenia gravis (MG) is an antigen-specific autoimmune disease caused by antibodies against acetylcholine receptors (AChR) at the post-synaptic membrane of the neuromuscular junction. Clinical and immunological data imply the involvement of AChR-specific T lymphocytes as helper cells for autoantibody production. Direct data to support this hypothesis, however, remain sparse. In the present study, a large population of MG patients was studied for evidence of peripheral blood T cell activation by several assays. Assays based on non-specific measurements of T cell activation as well as assays of antigen-specific clonal expansion were utilized. Levels of soluble IL-2 receptor in serum were modestly elevated in some patients, suggesting T cell activation. However, peripheral blood cells did not show evidence of IL-2 receptor expression or enhanced reactivity to IL-2 in culture. Clonable T cells selected for hypoxanthine phosphoribosyl transferase (hprt) mutation, another non-antigen-specific marker for T cell activation, were not seen with increased frequency except in patients treated with purine analogs. Antigen-specific T cell activation was measured by proliferation assays using heterologous and autologous sources of AChR. Antigen-restimulated peripheral blood cell cultures were cloned by limiting dilution. The vast majority of patients failed to show convincing evidence of AChR specific T cell activation or clonal expansion; only 2 of 44 patients demonstrated clonable autologous AChR-specific T cells. An alternative hypothesis of T cell involvement in MG is proposed in which T cell activation is discontinuous and predominantly directed at antigens other than AChR.
Journal of the American College of Cardiology, Jan 20, 2017
Currently, 2.2 million individuals are incarcerated, and more than 11 million have been released ... more Currently, 2.2 million individuals are incarcerated, and more than 11 million have been released from U.S. correctional facilities. Individuals with a history of incarceration are more likely to be of racial and ethnic minority populations, poor, and have higher rates of cardiovascular risk factors, especially smoking and hypertension. Cardiovascular disease is a leading cause of death among incarcerated individuals, and those recently released have a higher risk of being hospitalized and dying of cardiovascular disease compared with the general population, even after accounting for differences in racial identity and socioeconomic status. In this review, the authors: 1) present information on the cardiovascular health of justice-involved populations, and unique prevention and care conditions in correctional facilities; 2) identify knowledge gaps; and 3) propose promising areas for research to improve the cardiovascular health of this population. An Executive Summary of a National He...
free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource... more free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre-including this research content-immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and ... more Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and medical devices and other health system interventions. The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health system interventions. The concept of a “digital clinical trial” involves leveraging digital technology to improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation, and has the potential to transform clinical trials and to lower their cost. In April 2019, the US National Institutes of Health (NIH) and the National Science Foundation (NSF) held a workshop bringing together experts in clinical trials, digital technology, and digital analytics to discuss strategies to implement the use of digital technologies in clinical trials while considering potential challenges. This position paper builds on this workshop to describ...
Point-of-care technologies (POC or POCT) are enabling innovative cardiovascular diagnostics that ... more Point-of-care technologies (POC or POCT) are enabling innovative cardiovascular diagnostics that promise to improve patient care across diverse clinical settings. The National Heart, Lung, and Blood Institute convened a working group to discuss POCT in cardiovascular medicine. The multidisciplinary working group, which included clinicians, scientists, engineers, device manufacturers, regulatory officials, and program staff, reviewed the state of the POCT field; discussed opportunities for POCT to improve cardiovascular care, realize the promise of precision medicine, and advance the clinical research enterprise; and identified barriers facing translation and integration of POCT with existing clinical systems. A POCT development roadmap emerged to guide multidisciplinary teams of biomarker scientists, technologists, health care providers, and clinical trialists as they: 1) formulate needs assessments; 2) define device design specifications; 3) develop component technologies and integrated systems; 4) perform iterative pilot testing; and 5) conduct rigorous prospective clinical testing to ensure that POCT solutions have substantial effects on cardiovascular care.
BACKGROUND The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel R... more BACKGROUND The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study is a novel proof-of-concept study that evaluated the feasibility of extending the TAILOR-PCI randomized controlled trial (RCT) follow-up period by using a remote digital platform. OBJECTIVE The aim of this study is to describe patients’ onboarding, engagement, and results in a digital study after enrollment in an RCT. METHODS In this intervention study, previously enrolled TAILOR-PCI patients in the United States and Canada within 24 months of randomization were invited by letter to download the study app. Those who did not respond to the letter were contacted by phone to survey the reasons for nonparticipation. A direct-to-patient digital research platform (the Eureka Research Platform) was used to onboard patients, obtain consent, and administer activities in the digital study. The patients were asked to comple...
Aim-Modafinil was tested for efficacy in decreasing use in methamphetamine-dependent participants... more Aim-Modafinil was tested for efficacy in decreasing use in methamphetamine-dependent participants, compared to placebo. Methods-This was a randomized, double-blind, placebo-controlled study, with 12 weeks of treatment and a 4-week follow-up. Eight outpatient substance abuse treatment clinics participated
Aims-Topiramate has shown efficacy at facilitating abstinence from alcohol and cocaine abuse. Thi... more Aims-Topiramate has shown efficacy at facilitating abstinence from alcohol and cocaine abuse. This double-blind, placebo-controlled outpatient trial tested topiramate for treating methamphetamine addiction. Design-Participants (N=140) were randomized to receive topiramate or placebo (13 weeks) in escalating doses from 50 mg/day to the target maintenance of 200 mg/day in weeks 6-12 (tapered in week 13). Medication was combined with weekly brief behavioral compliance enhancement treatment. Setting-The trial was conducted at eight medical centers in the United States. Participants-One hundred forty methamphetamine-dependent adults took part in the trial. Measurements-The primary outcome was abstinence from methamphetamine during weeks 6-12. Secondary outcomes included use reduction versus baseline, as well as psychosocial variables.
IEEE Journal of Translational Engineering in Health and Medicine, 2016
The commercialization of new point of care technologies holds great potential in facilitating and... more The commercialization of new point of care technologies holds great potential in facilitating and advancing precision medicine in heart, lung, blood, and sleep (HLBS) disorders. The delivery of individually tailored health care to a patient depends on how well that patient's health condition can be interrogated and monitored. Point of care technologies may enable access to rapid and cost-effective interrogation of a patient's health condition in near real time. Currently, physiological data are largely limited to single-time-point collection at the hospital or clinic, whereas critical information on some conditions must be collected in the home, when symptoms occur, or at regular intervals over time. A variety of HLBS disorders are highly dependent on transient variables, such as patient activity level, environment, time of day, and so on. Consequently, the National Heart Lung and Blood Institute sponsored a request for applications to support the development and commercialization of novel point-of-care technologies through small businesses (RFA-HL-14-011 and RFA-HL-14-017). Three of the supported research projects are described to highlight particular point-of-care needs for HLBS disorders and the breadth of emerging technologies. While significant obstacles remain to the commercialization of such technologies, these advancements will be required to achieve precision medicine. INDEX TERMS Biosensor, commercialization, point-of-care technologies, precision medicine.
Aim-Modafinil was tested for efficacy in decreasing use in methamphetamine-dependent participants... more Aim-Modafinil was tested for efficacy in decreasing use in methamphetamine-dependent participants, compared to placebo.
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Papers by Erin Iturriaga