health analytics

May 8, 2020: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Real World Evidence: Contemporary Experience and Future Directions (Patrick Heagerty, PhD, Jacqueline Corrigan-Curay, JD, MD, Joshua C. Denny, MD, MS)

Posted on by Gina Uhlenbrauck

Speakers

Guest Moderator:
Patrick J. Heagerty, PhD
Professor, Department of Biostatistics, University of Washington

Panel:
Jacqueline Corrigan-Curay, JD, MD
Director of CDER’s Office of Medical Policy (OMP)
U.S. Food and Drug Administration (FDA)

Joshua C. Denny, MD, MS, FACMI
Chief Executive Officer, All of Us Research Program, NIH

Topic

Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Real World Evidence: Contemporary Experience and Future Directions

Keywords

Electronic health records; Real-world evidence; RWE; Real-world data; RWD; FDA; All of Us; Phenotypes; Regulatory; Fit-for-use data; Digital heath

Key Points

  • To create quality clinical/research records, we must design for multiuse by integrating standards-based tools in the EHR to bring together health care and research. 
  • Quality real-world evidence cannot be built without quality real-world data. With greater efficiencies in data capture, randomization with real-world data provides a pathway for reliable—and persuasive—real-world evidence.

Discussion Themes

Patient-generated health data is part of FDA’s MyStudies Application, designed to facilitate the input of real-world data directly by patients, which can be linked to electronic health data supporting traditional clinical trials, pragmatic trials, observational studies, and registries.

In assessing data quality we can ask, How does a data element travel from clinical care to a research data set?

The NIH’s All of Us program is building a diverse database that can inform thousands of studies on a variety of health conditions.

The All of Us study is tracking COVID-19 in its patients. Sites have identified their COVID-19 participants and relevant labs. Consent is obtained for future sharing of data.

Tags

#pctGR, @Collaboratory1

April 10, 2020: Hydroxychloroquine for the Early Treatment of COVID-19 in Hospitalized Adults: A Multicenter Randomized Clinical Trial (Sean Collins, MD, MSc)

Posted on by Gina Uhlenbrauck

Speaker

Sean Collins, MD, MSc
Professor and Executive Vice Chair
Department of Emergency Medicine
Director, Center for Emergency Care Research and Innovation
Vanderbilt University Medical Center

Topic

Hydroxychloroquine for the Early Treatment of COVID-19 in Hospitalized Adults: A Multicenter Randomized Clinical Trial

Keywords

Coronavirus; Virus pandemic; COVID-19; Randomized controlled trial; Acute respiratory distress syndrome (ARDS); Hydroxychloroquine; FDA; Emergency Use Authorization; ORCHID study

Key Points

  • Hydroxychloroquine is a biologically plausible agent for early treatment of acute respiratory distress syndrome in patients with COVID-19, but its effects remain to be evaluated in a high-quality, multicenter, blinded, placebo-controlled trial.
  • In an Emergency Use Authorization, the FDA has encouraged the conduct and participation in randomized controlled clinical trials that may produce evidence concerning the effectiveness of hydroxychloroquine in treating patients with COVID-19.
  • Trial results of the effects of this agent will be informative, whether showing benefit or harm.

Discussion Themes

The study team for this trial determined that one-to-one randomization would yield the best data quickly.

Efficacy and safety of hydroxychloroquine must be closely monitored in a health setting.

This is not the only study of chloroquine going on around the world; is there any collaboration with other studies?

Because of the urgency of the pandemic, people are collaborating on a level never seen before. We have a common goal and must maintain momentum through accelerating clinical trials with large teams of parallel studies.

Read more about this COVID-19 study at NCT04332991.

Tags
#pctGR, @Collaboratory1

April 3, 2020: Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): Participant-Centered, Rapidly-Deployed, Digitally-Enabled Research (Harlan Krumholz, MD; Bala Hota, MD, MPH; Graham Nichol, MD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

Harlan M. Krumholz, MD
Harold H. Hines Jr. Professor of Medicine, Yale University
Director, Yale New Haven Hospital Center for Outcomes Research and Evaluation
Co-Founder Hugo Health

Bala Hota, MD, MPH
Professor of Internal Medicine, Rush University
Chief Analytics Officer, Rush University Medical Center

Graham Nichol, MD, MPH
Medic One Foundation Endowed Chair for Pre-hospital Emergency Care
Professor of Emergency Medicine
University of Washington

Other Panelists:

Jacqueline Rollin, Administrative Fellow
Rush University Medical Center

Wade Schulz, MD, PhD
Assistant Professor of Laboratory Medicine
Director, CORE Center for Computational Health

Matthew J. Thompson, MB, ChB, DPhil
Helen D. Cohen Endowed Professorship in Family Medicine
Professor of Global Health and Medicine, University of Washington

Deb R. Chromik, Participant Experience
Hugo Health

Dave Hutton, Product Lead
Hugo Health

Topic

Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): Participant-Centered, Rapidly-Deployed, Digitally-Enabled Research

Keywords

Coronavirus; Virus pandemic; INSPIRE Registry; COVID-19 directed research program; SARS-COV-2; Longitudinal data; Hugo Health digital research platform

Key Points

  • In the face of the coronavirus pandemic, there is an urgent need for rapid knowledge generation and actionable insights. Evidence needed includes:
    • The number of cases, including milder ones
    • Risk factors and timing of transmission
    • Severity and attack rate
    • Risk factors for infection and severe outcomes, including death
    • Infectiousness timing and intensity
  • Patients must be considered part of the team; involved, engaged, and respected, with agency over their data.
  • To better understand the experience of people with COVID-19, Rush University Medical Center and Hugo health are piloting the COVID INSPIRE registry. INSPIRE is a rapidly-deployed, digitally-enabled, participant-centered platform to collect longitudinal data and facilitate observational and experimental studies.

Discussion Themes

Even with social distancing, the coronavirus is in a rapid escalation phase; this rapid pace has our attention.

People are interested in participating in research now more than ever. The call to action is to build a human-connected system that treats patients compassionately and supports patients in real time.

Are there existing systems that could be built on or adapted for COVID-19? Are there potential for linkages to other systems?

Tags
#pctGR, @Collaboratory1, @HMKYale, @BalaHota, @GrahamNichol

December 6, 2019: Millions More People, Stronger Collaborations: The New and Improved NIH Collaboratory Distributed Research Network (Richard Platt, MD, Kevin Haynes, PharmD, Denise Boudreau, PhD, Jerry Gurwitz, MD, Christopher Granger, MD)

Posted on by Gina Uhlenbrauck

Speakers

Richard Platt, MD, MS
Professor and Chair
Harvard Medical School
Department of Population Medicine

Kevin Haynes, PharmD, MSCE
Principal Scientist
HealthCore

Denise Boudreau, PhD
Senior Scientific Investigator
Kaiser Permanente Washington Health Research Institute

Jerry H. Gurwitz, MD
Professor of Medicine, Family Medicine and Community Health, and Population & Quantitative Health Sciences
University of Massachusetts Medical School
Executive Director, Meyers Primary Care Institute

Christopher B. Granger, MD
Professor of Medicine
Duke University

Topic

Millions More People, Stronger Collaborations: The New and Improved NIH Collaboratory Distributed Research Network

Keywords

Embedded clinical research; Distributed research network; Administrative claims data; Multisite research; Sentinel System; Electronic health data; National registries; Common data model; Curated research data

Key Points

  • The NIH Collaboratory Distributed Research Network (DRN) enables investigators funded by the NIH and other not-for-profit sponsors to collaborate with investigators based in health plans that participate in the FDA’s Sentinel System.
  • Examples from an array of real-world research studies highlight strengths of conducting collaborative research using the DRN.
  • Among the DRN’s attributes are the abilities to embed a randomized clinical trial in real-world clinical settings, to direct outreach to providers and patients/families, and to determine feasibility with high accuracy to allow confidence in planning of ambitious clinical trials.

Discussion Themes

The DRN is optimized for multicenter research and depends on partnerships. It was developed to enable productive research collaborations.

How do investigators who are not embedded in participating health systems learn to work effectively in the DRN?

Read more about the NIH Collaboratory’s DRN.

Tags
#pctGR, @Collaboratory1, @DeptPopMed, @HealthCoreRWE

October 18, 2019: Playing with FHIR–Innovative Use Cases for the New REDCap EHR Integration Module (Paul Harris, PhD)

Posted on by Gina Uhlenbrauck

Speaker

Paul A. Harris, PhD
Director, Office of Research Informatics
Professor of Biomedical Informatics, Biostatistics, and Biomedical Engineering
Vanderbilt University Medical Center

Topic

Playing with FHIR–Innovative Use Cases for the New REDCap EHR Integration Module

Keywords

Fast Healthcare Interoperability Resources; FHIR; Data interoperability; Electronic health record; EHR; Electronic data capture; Clinical data; Research informatics

Key Points

  • REDCap (Research Electronic Data Capture) is a robust, web-based data exchange platform developed at Vanderbilt to assist the research community in implementation efforts.
  • The REDCap consortium has more than a million users. The platform is available at no cost to academic, nonprofit, and government organizations who join the consortium.
  • Innovative use cases are being conducted with REDCap and an Epic EHR system to increase data flow and remove dependency on a data warehouse.

Discussion Themes

How can we harmonize the REDCap approach with PCORnet’s common data model (CDM)?

FHIR is an HL7 standard for exchanging healthcare information electronically. Another use case integrates FHIR to democratize EHR extraction methods to improve efficiency in multisite clinical data collection.

How can researchers manage many-to-one mapping; for example, if the electronic case report form (CRF) has one field value but there are many values in the record?

Read more about the REDCap project.

Tags
#pctGR, @Collaboratory1

September 6, 2019: Transforming Medical Evidence Generation with Technology-Enabled Trials (Matthew T. Roe, MD MHS)

Posted on by Gina Uhlenbrauck

Speaker

Matthew T. Roe, MD, MHS
Senior Investigator, Professor of Medicine
Duke Clinical Research Institute

Topic

Transforming Medical Evidence Generation with Technology-Enabled Trials

Keywords

Mobile clinical trials; Real-world evidence; Real-world data; Study design; Regulatory oversight; Digital health; Mobile health applications; Biosensors; Electronic health records

Key Points

  • Digital health applications and electronic health records provide tremendous opportunities for improving trial efficiencies, broadening patient participation, and reducing cost.
  • Novel approaches that can help reduce data collection burden for study sites include importing EHR data directly into the trial database, collecting patient-reported outcomes through web-based portals, and incorporating digital health data from wearables and biosensors.
  • To realize the potential of new technology, cross-sectional partnerships are needed among research participants, researchers, biopharma device industries, professional medical associations, insurers, FDA, clinicians, health IT, contract research organizations, and health systems.

Discussion Themes

How many potential patients might we lose if having a smart phone is an inclusion criterion for a clinical study?

How can we ensure that the clinical trial infrastructure is inclusive of minority populations, especially those in rural settings?

What is the role of physicians in reaching a large number of participants who are not near an academic research center?

Ultimately, in clinical trials, the data are what matter and what decisions are based on. We need to understand data quality and standards for the data to be accepted.

Read more about digital health at FDA’s Digital Health website.

Tags

#pctGR, @Collaboratory1, @MTRHeart

August 16, 2019: Introducing the Digital Medicine Society (Andy Coravos, MBA, Jen Goldsack, MS, MBA)

Posted on by Gina Uhlenbrauck

Speakers

Andy Coravos
CEO, Elektra Labs
Fellow, Harvard-MIT Center for Regulatory Science
Co-founder, Digital Medicine Society (DiMe)

Jen Goldsack, MS, MBA
Interim Executive Director, DiMe
Portfolio, Strategy & Ops, HealthMode

Topic

Introducing the Digital Medicine Society

Keywords

Digital medicine; Mobile health; Digital technologies; Wearable health devices; Connected devices; Cybersecurity

Key Points

  • Digital medicine is a rapidly evolving field that is by nature multidisciplinary and introduces new considerations for the healthcare community.
  • The Digital Medicine Society (DiMe) sits at the intersection of two communities: healthcare and technology. The Society is helping to move the field of digital medicine forward by developing a common language for diverse stakeholders from engineers and ethicists to payers and providers.
  • The U.S. healthcare system has strong protections for patients’ biospecimens like blood or genomic data, but what about digital specimens?

Discussion Themes

Are digital medical technologies worthy of the trust we place in them?

Should there be a Hippocratic Oath for manufacturers, organizations, and individuals delivering care through connected medical devices?

Read more about the emerging field of digital medicine and learn more about the Digital Medicine Society (DiMe), the professional home for those who practice and develop products in the digital era of medicine.

Tags

#DigitalMedicine, #pctGR, @Collaboratory1, @_DiMeSociety

August 2, 2019: AI and the Future of Psychiatry (Murali Doraiswamy, MBBS)

Posted on by Gina Uhlenbrauck

Speaker

Murali Doraiswamy, MBBS
Professor of Psychiatry and Behavioral Sciences
Duke School of Medicine

Topic

AI and the Future of Psychiatry

Keywords

Artificial intelligence; Machine learning; Psychiatry; Ethical adoption of technologies; Mental health; Wearables; Mobile health

Key Points

  • There is growing evidence from randomized controlled trials of the efficacy of using digital tools in mental health diagnosis and treatment.
  • Could artificial intelligence (AI) and machine learning technologies be used to:
    • Reduce the stigma associated with mental health treatment?
    • Predict the risk for future suicide?
    • Detect Alzheimer’s years before diagnosis?
  • Categories of AI applications include low-risk apps that measure but do not diagnose, and apps used in diagnosis or treatment that must meet the same high standards of evidence as medications.
  • Clinicians still struggle with how to integrate patient data from wearable devices. AI technology might help if it could be used to synthesize the data into a risk profile for an individual.

Discussion Themes

What are the roles of stress, exercise, and sleep in mental health, and can autonomic data from wearables help explain the variance in mental health symptoms?

To develop evidence thresholds for AI, we need larger scale public-private partnerships as well as pragmatic trials addressing key clinical questions.

Read more from Dr. Doraiswamy in How to Use Technology Ethically to Increase Access to Mental Healthcare.
Tags

#AI, #pctGR, @Collaboratory1

July 26, 2019: Digital in Trials: Improving Participation and Enabling Novel Endpoints (Craig H. Lipset)

Posted on by Gina Uhlenbrauck

Speaker

Craig H. Lipset
Former Head of Clinical Innovation, Pfizer

Topic

Digital in Trials: Improving Participation and Enabling Novel Endpoints

Keywords

Digital tools; Clinical trials; Participant experience; Patient engagement; Clinical Trials Transformation Initiative

Key Points

  • To improve trial participation, start by understanding the user/consumer; ie, the trial participant and his or her trial experience.
  • Digital improvements in clinical trials can involve these incremental steps:
    • Study planning that is data-driven, crowdsourced, and informed by artificial intelligence
    • Patient engagement that implements electronic consent, flexibility in location, digital concierge support, and data ownership
    • Study conduct that integrates remote monitoring, digital biomarkers, and electronically sourced data
    • Analysis and reporting that is automated and includes dissemination to trial participants

Discussion Themes

Will digital tools in medicine development enable improvement, disruption, or displacement?

Digital tools in development focus on breaking down barriers to participation, using digital to improve existing measurement or enable new endpoints, and automating processes and tasks while improving quality.

Tags

#pctGR, @Collaboratory1

July 2, 2019: New Living Textbook Section on Inpatient Endpoints in Pragmatic Clinical Trials

Posted on by Karen Staman

A new section in the Living Textbook describes the considerations for using “real-world” data for inpatient-based event ascertainment. There are many sources for acquiring this information, and they have different time lags in their availability and varying degrees of error and bias. In order to use inpatient endpoints in pragmatic clinical trials, these factors must be understood during the design, conduct, and analysis phases of an embedded pragmatic clinical trial.

“The pragmatic trial community needs to collectively determine which endpoints are relevant for pragmatic trials, how they can be measured and validated, and how the accuracy of these measurement methods may impact hypothesis testing sample size estimates.” —Eisenstein et al 2019

Topics in the chapter include:

  • Pragmatic trial inpatient endpoints
  • Inpatient event data sources
  • Patient-reported data
  • Secondary data sources: EHR
  • Secondary data sources: claims
  • Case studies: ICD-Pieces, TRANSFORM-HF, ADAPTABLE, and TRANSLATE ACS
  • Data source accuracy