Grand Rounds April 29: BP Track: National Surveillance for Blood Pressure Control and Related Process Metrics Using PCORnet (Mark J. Pletcher, MD, MPH; Rhonda Cooper-DeHoff, PharmD, MS; Alanna M. Chamberlain, PhD, MPH)

Speakers:

Mark J. Pletcher, MD, MPH
Professor of Epidemiology and Biostatistics and Medicine
University of California, San Francisco

Rhonda Cooper-DeHoff, PharmD, MS, FAHA, FACC, FCCP
Association Professor and Research Foundation Professor
University of Florida College of Pharmacy

Alanna M. Chamberlain, PhD, MPH
Associate Professor of Epidemiology
Mayo Clinic

Topic: BP Track: National Surveillance for Blood Pressure Control and Related Process Metrics Using PCORnet

Date: Friday, April 29, 2022, 1:00-2:00 p.m. ET

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June 5, 2020: PCORnet COVID-19 Common Data Model Design and Results (Thomas Carton, PhD, MS; Keith Marsolo, PhD; Jason Perry Block, MD, MPH)

Speakers

Thomas W. Carton, PhD, MS
Chief Data Officer
Louisiana Public Health Institute

Keith Marsolo, PhD
Associate Professor
Department of Population Health Sciences
Duke Clinical Research Institute
Duke University School of Medicine

Jason Perry Block, MD, MPH
Associate Professor of Population Medicine
Department of Population Medicine Harvard
Pilgrim Health Care Institute
Harvard Medical School

Topic

PCORnet COVID-19 Common Data Model Design and Results

Keywords

COVID-19; PCORnet; Common Data Model; CDM; Data query; Health disparities; Distributed data network

Key Points

  • For data to be useful in research, they have to be standardized across systems. The PCORnet Common Data Model standardizes data into a single language, enabling fast insights.
  • All the core data elements needed to support COVID-19 research and surveillance have a home in the PCORnet CDM. The goal for PCORnet is to characterize the cohort of COVID-19 patients and provide detailed information on demographics and pre-existing conditions.

Discussion Themes

Can PCORnet partners stand up a version of the CDM with more up-to-date information to allow for a faster characterization of the PCORnet COVID-19 population?

Is there a query to discover and address COVID-19 health disparities and social determinants of health?

Can PCORnet and NCATS’ National COVID Cohort Collaborative (N3C) work together?

Read more about PCORnet’s code lists and case definitions on GitHub.

Tags

#COVID19, #pctGR, @Collaboratory1

June 3, 2020: NIH Collaboratory COVID-19 Grand Rounds Series Continues With the PCORnet COVID-19 Common Data Model

The NIH Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.

In this week’s COVID-19 Grand Rounds session, Dr. Thomas Carton of the Louisiana Health Institute, Dr. Keith Marsolo of Duke University, and Dr. Jason Block of Harvard Pilgrim Health Care Institute will present “PCORnet COVID-19 Common Data Model Design and Results.” The Grand Rounds session will be held on Friday, June 5, at 1:00 pm eastern. Join the online meeting.

Previous COVID-19 Grand Rounds:

For more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

May 14, 2020: Healthcare Workers Invited to Join the HERO Registry

The Healthcare Worker Exposure Response & Outcomes (HERO) Registry invites both clinical and nonclinical healthcare workers to share their life experiences in order to understand the perspectives and problems faced by those on the COVID-19 pandemic frontlines. HERO Registry participants could have the opportunity to participate in future research studies to improve the understanding of COVID-19 and beyond, generating evidence to help healthcare workers stay safe and healthy.

The HERO Registry is open to all healthcare workers, including nurses, therapists, physicians, emergency responders, food service workers, environmental service workers, interpreters, transporters — anyone who works in a setting where people receive health care.

Learn more about the HERO Registry and how to join.

Don’t miss the recent COVID-19 Grand Rounds introducing the HERO Program and get the latest information and resources on COVID-19 for clinical researchers.

April 22, 2020: New Article Details the Design of ADAPTABLE, PCORnet’s First Pragmatic Trial

A new article in JAMA Cardiology discusses the design of ADAPTABLE, a pragmatic clinical trial (PCT) which strives to answer a three-decade-old question with great potential significance for public health. ADAPTABLE is the first PCT to use many of the data-driven and patient-centric capabilities of the National Patient-Centered Clinical Research Network (PCORnet).

Researchers in ADAPTABLE pursued the unanswered question of whether a low dose or high dose of aspirin is optimal for secondary prevention of atherosclerotic cardiovascular disease. Complexities of running a randomized clinical trial and the expenses associated with it have previously prevented researchers from answering this question.

The capabilities of PCORnet have aided in this research. Though not all randomized clinical trials can be designed as PCTs, ADAPTABLE demonstrates the possibility of incorporating pragmatic elements into future studies with the goal of producing real-world evidence.

A key objective of involving PCORnet in ADAPTABLE was the ability for large-scale recruitment (15,000 participants) using electronic health records and electronic informed consent. The PCORnet component permitted complete electronic participation, from randomization to data collection. Patients reported their own data during scheduled electronic follow-ups, which replaced conventional follow-up visits.

NIH Collaboratory Coordinating Center co–principal investigator Dr. Adrian Hernandez also serves as co–principal investigator of ADAPTABLE and contributed to the article.

See the accompanying editorial describing lessons learned from the design features of ADAPTABLE.

November 15, 2019: PCORnet: Health Plan Research Network Data Linkage and Patient Engagement with Patient-Powered Research Networks (Kevin Haynes, PharmD, MSCE)

Speaker

Kevin Haynes, PharmD, MSCE
Principal Scientist
HealthCore

Topic

PCORnet: Health Plan Research Network Data Linkage and Patient Engagement with Patient-Powered Research Networks

Keywords

Data linkages; PCORnet; Patient-powered research networks; Health plan research networks; Computable phenotypes

Key Points

  • One of the biggest challenges facing healthcare today is reducing gaps in evidence necessary to improve health outcomes. Research collaborations between health plans and patient-powered research networks (PPRNs) can help close this gap.
  • PCORnet enables linkages with patient groups through PPRNs, which include participating organizations and leadership teams of patients, advocacy groups, clinicians, academic centers, and practice-based research networks.
  • From the health plan perspective, postal mail outreach to members was more effective than email outreach around engaging patients in research opportunities.

Discussion Themes

When engaging with different patient-powered research networks, are there differences around common conditions compared with rare or stigmatized conditions?

What are participants told about the commercialization of findings, whether in terms of new treatments that might be identified, or the ways in which findings might affect health plans’ willingness to continue to cover certain treatments?

An essential aspect of collaboration is building and maintaining the trust of members in the research networks.

Read more about collaborations between PPRNs and health plans in a recent JAMIA publication and the PCORnet website.

Tags
#pctGR, @Collaboratory1, @KHaynes001

September 13, 2019: ADAPTABLE Recruitment and Follow-up: Health Plan Research Network Engagement (Kevin Haynes, PharmD, MSCE)

Speaker

Kevin Haynes, PharmD, MSCE
Principal Scientist
HealthCore, Inc.

Topic

ADAPTABLE Recruitment and Follow-up: Health Plan Research Network Engagement

Keywords

Real-world evidence; Real-world data; Study design; Claims data; ADAPTABLE; Patient recruitment; Pragmatic clinical trial; Electronic health record; Informed consent; Learning health system

Key Points

  • We need integrated EHR data and claims data in order to close evidence gaps in observational pharmacoepidemiology studies and comparative effectiveness trials.
  • The health plan claims data environment can be leveraged to support real-world evidence studies.
  • An integrated health plan network database can be a resource for data about eligibility, lab test results, and pharmacy claims. In a pragmatic clinical trial, using health plan data can provide a longitudinal electronic approach to endpoint ascertainment.

Discussion Themes

Have you had a chance to do any cost analysis of this high-volume, low-touch method of recruitment?

In the ADAPTABLE enrollment portal, it seems the biggest chunk of time (reading about the study) came before the screening questions. Do you think swapping the order might have improved enrollment?

Read more about the ADAPTABLE pragmatic trial.

Tags

#pctGR, @Collaboratory1, @HealthCoreRWE

June 13, 2019: Experience With Pragmatic Clinical Trials Gains Momentum

At the NIH Collaboratory Steering Committee Meeting in May 2019, participants shared their perspectives on the evolving landscape of embedded pragmatic clinical trials (ePCTs). Three initiatives were presented: the Patient-Centered Outcomes Research Institute (PCORI), the NIH-DoD-VA Pain Management Collaboratory, and the HEAL (Helping to End Addiction Long-term) Initiative. Although many challenges remain, the conduct of ePCTs is gaining momentum, and the synergy between the initiatives, along with the fellowship they engender, will continue to help pave the way for more embedded pragmatic research in the future.

Dr. Ann Trontell, Associate Director of Clinical Effectiveness and Decision Science at PCORI, shared PCORI’s experience with pragmatic clinical studies. Since 2014, PCORI has awarded $494 million dollars for 43 pragmatic studies that range in size from 425 to 100,000 participants (median, approximately 1700). The studies include 2 observational, 27 individually randomized, and 14 cluster randomized trials in a wide range of therapeutic areas.

Dr. Trontell urged those developing proposals for pragmatic trials to make them fit for purpose, as opposed to emphasizing pragmatism, a theme echoed in the Developing a Compelling Grant Application chapter of the Living Textbook.

 

 

 

 

Dr. Robert Kerns, a director of the NIH-DoD-VA Pain Management Collaboratory, shared progress with pragmatic trials designed to evaluate whether evidence-based nonpharmacological approaches are effective for pain management among US military personnel and veterans.

Modeled after the NIH Collaboratory, the Pain Management Collaboratory is supporting 11 projects through a 2-year planning phase and a 2- to 4-year implementation phase. Subject matter experts at the Pain Management Collaboratory Coordinating Center (PMC3) support the projects by sharing tools, best practices, and resources.

 

Dr. Wendy Weber, Program Officer for the NIH Collaboratory Coordinating Center, introduced the HEAL initiative, which is designed to enhance pain management and improve prevention and treatment strategies for opioid misuse and addiction. The goal of the initiative is to provide scientific solutions to the opioid crisis. It includes a set of large-scale pragmatic trials that will receive logistical and technical support from the NIH Collaboratory Coordinating Center.

 

While experience with ePCTs is growing, many distinct challenges remain. As the conduct of ePCTs gains momentum, there is a rich opportunity to use collective experiences to refine best practices to real-world evidence generation and help solve urgent public health problems.

August 28, 2018: ADAPTABLE Patient-Reported Health Data Codes Now Available

The ADAPTABLE pragmatic trial relies on patients to report key information at baseline and throughout follow-up. To capture these data, ADAPTABLE investigators developed a LOINC (Logical Observation Identifiers Names and Codes) patient-reported item set, which is now publicly available.

The development of the item set is part of the ADAPTABLE Supplement, an initiative funded by the Office of the Assistant Secretary for Planning and Evaluation to develop best practices for capturing patient-reported outcome data and optimal analytic approaches for using the data in a pragmatic clinical trial. Additional reference material can be found in the ADAPTABLE Supplement Roundtable Meeting summary, in a report describing the results of a literature review of data standards and metadata standards for variables of interest, and on GitHub. The project is expected to inform future efforts to integrate patient-reported data in the electronic health record and provide opportunities to streamline data for use in pragmatic trials. Information from the project is being added to the Living Textbook as it accumulates; learn more in the chapters on Using Electronic Health Record Data and Choosing and Specifying End Points and Outcomes.

ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) aims to identify the optimal dose of aspirin therapy for secondary prevention in atherosclerotic cardiovascular disease and is the first major randomized comparative effectiveness trial to be conducted by the National Patient-Centered Clinical Research Network (PCORnet).

Special Issue Published on Ethical & Regulatory Complexities of Pragmatic Clinical Trials


Tools for ResearchA new series of 12 articles published in a special issue of the journal Clinical Trials addresses ethical and regulatory challenges particular to pragmatic clinical research. Pragmatic clinical trials are designed to efficiently provide answers to important clinical questions, yet they present special challenges in conforming to the ethical and regulatory guidelines that were developed for more traditional clinical research. The special issue describes these challenges and begins to outline possible solutions that will protect the rights and welfare of research participants while allowing pragmatic clinical trials to gather much-needed evidence for informing healthcare decisions. An introductory article is followed by 11 articles addressing individual topics, such as alteration of informed consent, privacy, gatekeepers, and defining minimal risk research. The effort was funded by the NIH Health Care Systems Research Collaboratory, with additional support from the Patient-Centered Outcomes Research Institute (PCORI), and involved diverse groups of stakeholders, including researchers, patient advocates, bioethicists, and regulatory experts. Robert M. Califf, MD, and Jeremy Sugarman, MD, MPH, were editors of the special issue.

For more information: