research tools

November 22, 2019: It’s Time to Learn From Patients Like Mine (Nigam H. Shah, MBBS, PhD)

Posted on by Gina Uhlenbrauck

Speaker

Nigam H. Shah, MBBS, PhD
Associate Professor of Medicine
Stanford University

Topic

It’s Time to Learn From Patients Like Mine

Keywords

Clinical informatics; Clinical data warehouse; Aggregate patient data; Consult service; Cohort search engine

Key Points

  • The “Green Button” service consists of software, data, and personnel. Multiple datasets are used in the analysis, along with a human filter.
  • The search engine can find matching patients by searching across diagnosis and procedure codes, concepts extracted from clinical notes, laboratory test results, vital signs, as well as visit types and duration of inpatient stays, and then compare their outcomes.
  • Questions that remain include:
    • Does having such a consult service change patient outcomes?
    • How could we enable such consults nationwide?
    • Could we automate such analyses to be “always on”?
    • Could we get such a “curbside consult” from multiple health systems?
    • Could patients benefit from having access to such reports?

Discussion Themes

Could this technology be applied in emergent, critical patient settings where the care is more diagnostic, and where predictive modeling using health system data could be helpful?

What’s missing from the data that would improve accuracy or relevance? For example, social, demographic, and environmental data.

Read more about Stanford’s Green Button clinical informatics consult project.

Tags
#pctGR, @Collaboratory1

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

Posted on by Gina Uhlenbrauck

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

October 25, 2019: Real-World Evidence for Drug Effectiveness Evaluation: Addressing the Credibility Gap (Richard Willke, PhD)

Posted on by Gina Uhlenbrauck

Speaker

Richard Willke, PhD
Chief Science Officer
ISPOR

Topic

Real-World Evidence for Drug Effectiveness Evaluation: Addressing the Credibility Gap

Keywords

Real-world evidence; Non-interventional studies; Health economics; ISPOR; Transparency; Reproducibility

Key Points

  • ISPOR is an international, multistakeholder nonprofit dedicated to advancing health economics and outcomes research excellence to improve decision making for health globally.
  • Key characteristics of credible and useful real-world evidence include:
    • Careful data collection or curation
    • Appropriate analytic methods
    • Good procedural practices for transparent study process
    • Replicability and reproducibility
    • Informed interpretation
    • Fit-for-purpose application
  • For transparency, it is recommended that researchers declare their study to be an exploratory (hypothesis evaluation) study and post the study protocol and analysis plan on a public study registration site prior to conducting the study analysis.

Discussion Themes

A draft white paper, Improving Transparency in Non-Interventional Research, is available for comment until November 15, 2019.

Sharing all study implementation parameters and definitions provides clarity on what was actually done and enables reproduction with confidence.

Potential registries for non-interventional real-world evidence studies include:

Read more about ISPOR.

Tags
#pctGR, @Collaboratory1, @ISPORorg

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 27, 2019: Preparing for Clinical Trial Data Sharing and Re-use: The New Reality for Researchers (Rebecca Li, PhD, Frank Rockhold, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Rebecca Li, PhD
Executive Director, Vivli
Co-Director of Research Ethics, Harvard Center for Bioethics
Harvard Medical School

Frank W. Rockhold, PhD
Professor of Biostatistics and Bioinformatics
Duke Clinical Research Institute
Duke University Medical Center

Topic

Preparing for Clinical Trial Data Sharing and Re-use: The New Reality for Researchers

Keywords

Data sharing; Individual patient data; Open access; Raw data; ICMJE; Research dissemination

Key Points

  • Open access to individual patient data from clinical trials is a critical tool for research in health care. Despite the challenges, the question is not whether data should be shared, but rather how and when access should be granted.
  • Preparing data for reuse is often an afterthought—yet it is a new reality for researchers and institutions.
  • As of January 1, 2019, the International Committee of Medical Journal Editors (ICMJE) requires registration of a trial’s data sharing plan at the time of trial registration.
  • Institutions or teams should begin their data sharing program planning at least 18 months before a major publication (or regulatory approval).

Discussion Themes

FAIR data are data that meet standards of findability, accessibility, interoperability, and reusability.

How do we manage scientific integrity, replication, and validity given that data sharing opens a study to multiple people asking the same or related questions in potentially different ways using different methods?

How do we plan for a future that rewards data quality and reuse?

Read more about data sharing from ICMJE, NIH Office of Science Policy, and the National Academy of Medicine.

Tags

#pctGR, @Collaboratory1, @VivliCenter, @FrankRockhold

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

Posted on by Gina Uhlenbrauck

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

August 23, 2019: Oh Yes, We Have Tons of Patients Who Can Do This Study! (Vanita R. Aroda, MD)

Posted on by Gina Uhlenbrauck

Speaker

Vanita R. Aroda, MD
Director of Diabetes Clinical Research
Brigham & Women’s Hospital
Harvard Medical School

Topic

Oh Yes, We Have Tons of Patients Who Can Do This Study!

Keywords

Patient engagement; Patient recruitment and retention; Clinician engagement; Health care systems; Multicenter clinical trials; Electronic health record

Key Points

  • Research occurs beyond the silo. Effective large-scale multicenter clinical trial recruitment requires an accessible network of potential participants.
  • Engage colleagues and the healthcare system as part of the collaborative journey across the trial’s lifecycle.
  • It is highly recommended to do a role-playing exercise with the study team to prevent fumbles when engaging and recruiting study participants.
  • The science, the protocols, and the data are all important, but it is the essential human element that makes it all happen.

Discussion Themes

Participant retention is really a continuation of good recruitment and engagement.

Make sure your database query makes clinical sense and is the best fit to answer your study question. Don’t spend time on the wrong data.

What other recruitment opportunities or techniques can sites use after they exhaust their patient panel?

Read more about the scalability of an EHR-based approach to patient recruitment in a diabetes study by Dr. Varoda and colleagues in Clinical Trials (2019).

Tags

#pctGR, @Collaboratory1

August 9, 2019: Open Science: Are we there yet? (Adrian Hernandez, MD)

Posted on by Gina Uhlenbrauck

Speaker

Adrian Hernandez, MD
Professor of Medicine
Vice Dean for Clinical Research
Duke University, School of Medicine

Topic

Open Science: Are We There Yet?

Keywords

Open science; Data sharing; Secondary analyses; Research collaboration

Key Points

  • Open science involves the responsible sharing of research data for the purpose of scientific advancement, integrity, and transparency.
  • Various stakeholders have made progress toward sharing clinical trial data, including:
  • Guiding principles of open science include appropriate access to research information; proper oversight with minimum barriers to data access; maintaining utility of data; an expectation that results of shared data will similarly be shared; and acknowledgment of those who contribute original data.
  • Despite efforts at supporting open science, no academic institution has an open science policy yet.

Discussion Themes

Open science remains an important goal to build trust and expand knowledge.

Data sharing is not a traditional measure of academic success. What incentives would need to change in order to support open science?

Tags

#OpenScience, #DataSharing, #pctGR, @Collaboratory1, @texhern

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 12, 2019: medRxiv: A Paradigm Shift in Disseminating Clinical and Public Health Research (Harlan Krumholz, MD, SM, Joseph Ross, MD, MHS)

Posted on by Gina Uhlenbrauck

Speakers

Harlan M. Krumholz, MD, SM
Harold H. Hines, Jr. Professor of Medicine and Public Health
Yale University

Joseph S. Ross, MD, MHS
Associate Professor of Medicine and Public Health
Yale University

Topic

medRxiv: A Paradigm Shift in Disseminating Clinical and Public Health Research

Keywords

Open science; Clinical research dissemination; Preprints; medRxiv preprint server

Key Points

  • medRxiv (med archive) is a server for health science preprints. It is a free service to the research community, managed in partnership with BMJ and Yale.
  • Benefits of preprints in medicine include early sharing of new information; enabling less “publishable” studies to be more readily available; and facilitating replication and reproducibility studies.
  • medRxiv submissions require:
    • Following ICMJE guidance, including author names, contact info, affiliation
    • Funding and competing interests statements
    • Statement of IRB or ethics committee approval
    • Study registration (ClinicalTrials.gov or other ICMJE approved registry for trials, PROSPERO for reviews) or link to protocol
    • Data sharing availability statement
    • EQUATOR Network reporting guidelines checklists
  • The medRxiv preprint server urges caution in using and reporting preprints, and includes language explaining that preprints are preliminary reports of work that have not been peer-reviewed, should not be relied on to guide clinical practice or health-related behaviors, and should not be reported in news media as established information.

Discussion Themes

Preprint servers do not replace, but rather complement, peer review.

Preprint has the potential for being a vehicle for high-quality but “negative” results. If we teach students that a negative result is also a good result, providing an avenue for us to walk-the-talk more easily via open communication seems largely positive despite the limitations.

Read more about medRxiv.

Tags

#pctGR, @Collaboratory1, @jsross119, @hmkyale