ME/CFS Patients Are Enrolling in NIH's "All of Us" Research Study

Gemini

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Seven hundred ME/CFS patients have enrolled to date in NIH's "All of Us" Precision Medicine Research Study according to information posted on NIH's "Open Access" Research Hub this month.

The study's goal is to enroll one million or more U.S. participants over the next 5-6 years focusing on those understudied in the past collecting genetic data, biological samples, Electronic Health Records, survey data and much more for each participant over time. Big Data tools/techniques will be used to analyze the data hopefully leading to new discoveries.

In 2015 President Obama called for a nationwide "Precision Medicine Initiative"; $215 million was allocated to get it started. One year ago the "All of Us" study was launched as part of the Initiative with 230,000 people in total enrolled to date.

A Special 1 1/2 hour videocast was made May 6, 2019 hosted by Dr. Francis Collins,
NIH Director, to celebrate the on-going progress and plans for the "All of Us" study. It's worth a watch:

https://videocast.nih.gov/summary.asp?Live=31677&bhcp=1

NIH's "Open Access" Research Hub has a "Search" feature for browsing the survey data. Enter "Chronic Fatigue Syndrome," or the name of any condition, and data collected is displayed. For example, for "Multiple Sclerosis", it shows 320 patients enrolled plus additional data collected. This openness is a huge and welcome change to research business as usual for sure!

https://researchallofus.org

Developers of the user interface and data platform are requesting user feedback and suggestions for improvements which can be submitted to: support@researchallofus.org
 
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Gemini

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Individuals interested in joining the "Precision Medicine Initiative" research study can enroll:

(1) through participating health care provider organizations (HPOs), or

(2) directly through JoinAllofUs.org.

The following HPOs have been selected as the initial set of HPOs with the expectation that additional organizations will be added over time.

Regional Medical Centers:

  • All of Us, Wisconsin
    • Marshfield Clinic Research Institute
    • BloodCenter of Wisconsin, Milwaukee
    • Froedtert & Medical College of Wisconsin, Milwaukee
    • University of Wisconsin School of Medicine and Public Health in Madison
  • California Precision Medicine Consortium
    • University of California San Diego (lead)
    • Cedars-Sinai Medical Center, Los Angeles
    • San Diego Blood Bank
    • University of California, Davis
    • University of California, Irvine
    • University of California, San Francisco
    • University of Southern California, Los Angeles
  • Illinois Precision Medicine Consortium
    • Northwestern University, Chicago
    • University of Chicago
    • University of Illinois at Chicago
    • NorthShore University HealthSystem, Chicago
    • Rush University Medical Center, Chicago
  • All of Us New England
    • Partners HealthCare System (lead) and its founding hospitals, Brigham and Women’s Hospital and Massachusetts General Hospital
    • Boston Medical Center
    • Newton-Wellesley Hospital
  • New York City Precision Medicine Consortium
    • Columbia University Medical Center, New York City (lead)
    • NYC Health + Hospitals/Harlem, New York City
    • NewYork-Presbyterian, New York City
    • Weill Cornell Medicine, New York City
  • Southern All of Us Network
    • University of Alabama at Birmingham (UAB)
    • Cooper Green Mercy Health Services, Birmingham, Alabama
    • Huntsville Hospital, Alabama
    • Louisiana State University Health Sciences Center, New Orleans
    • Tulane Medical Center, New Orleans
    • Tuskegee University, Alabama
    • UAB Hospital, Birmingham, Alabama
    • UAB School of Medicine’s Montgomery Internal Medicine and Selma Family Medicine programs, Birmingham, Alabama
    • University of Mississippi Medical Center, Jackson
    • University of South Alabama Health System, Mobile
    • University Medical Center, Tuscaloosa, Alabama
  • SouthEast Enrollment Center
    • University of Miami Miller School of Medicine, Florida
    • Emory University, Atlanta
    • Morehouse School of Medicine, Atlanta
    • OneFlorida Clinical Research Consortium led by the University of Florida in Gainesville
  • Trans-American Consortium for the Health Care Systems Research Network
    • Henry Ford Health System, Detroit (lead)
    • Baylor Scott and White Health, Dallas
    • Spectrum Health, Grand Rapids, Michigan
    • Essentia Institute of Rural Health, Minnesota
    • Reliant Medical Group, Massachusetts
  • University of Arizona, Tucson
    • Banner Health, Phoenix
  • University of Pittsburgh at Pittsburgh
Health Center Pilot Sites
  • Cherokee Health Systems, Knoxville, Tennessee
  • Community Health Center, Inc., Middletown, Connecticut
  • Eau Claire Cooperative Health Center, Columbia, South Carolina
  • HRHCare, Peekskill, New York
  • Jackson-Hinds Comprehensive Health Center, Jackson, Mississippi
  • San Ysidro Health, San Ysidro, California
U.S. Department of Veterans Affairs Medical Centers
  • NIH will work with the VA to select a number of VA medical centers that will invite veterans to participate in the All of Us Research Program.
 
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Gemini

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June 24, 2019: a status report on the "All Of Us Research Program" was presented at a 2-day NIH Workshop titled "All Of Us Research Program Ethical, Legal & Social Implications (ELSI)":

Research Program announcements that may be of interest to the ME/CFS community:

* There are now 358 NIH designated sites nationwide for participants to access the Program

* In addition, locations at Walgreen's Pharmacies and Quest Diagnostics Labs will be participating

* To reach rural, homebound, and others not near a Program site, in-home visiting services are planned

* The Fitbit company is participating; 3000 participants are currently providing their wearables data

* Whole genome sequencing of all those enrolled will begin by the end of 2019. Participants will receive their test results and their data throughout the study.

https://videocast.nih.gov/summary.asp?Live=33236&bhcp=1
 

Wally

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@Gemini - I think one of the concerns people may have in signing up to participate in projects like this relates to how safe/protected is all the personal information that would be provided to be part of this research. Here is a recent article that highlights why being concerned about the technology and safeguards in place to receive, store and share this information is a very important part of deciding whether or not to share personal information on such a large scale.
https://www.sciencedaily.com/releases/2019/07/190702152755.htm
Personalized medicine software vulnerability uncovered

Discovery led researchers to software fix
Date:
July 2, 2019


Source:
DOE/Sandia National Laboratories

Summary:
A weakness in one common open source software for genomic analysis left DNA-based medical diagnostics vulnerable to cyberattacks. Researchers identified the weakness and notified the software developers, who issued a patch to fix the problem. The issue has also been fixed in the latest release of the software, and no attack from this vulnerability is known. . . . .


The discovery reveals that protecting genomic information involves more than safe storage of an individual's genetic information. The cybersecurity of computer systems analyzing genetic data is also crucial, said Corey Hudson, a bioinformatics researcher at Sandia who helped uncover the issue.

Personalized medicine -- the process of using a patient's genetic information to guide medical treatment -- involves two steps: sequencing the entire genetic content from a patient's cells and comparing that sequence to a standardized human genome. Through that comparison, doctors identify specific genetic changes in a patient that are linked to disease.

Genome sequencing starts with cutting and replicating a person's genetic information into millions of small pieces. Then a machine reads each piece numerous times and transforms images of the pieces into sequences of building blocks, commonly represented by the letters A, T, C and G. Finally, software collects those sequences and matches each snippet to its place on a standardized human genome sequence. One matching program used widely by personalized genomics researchers is called Burrows-Wheeler Aligner (BWA).

Sandia researchers studying the cybersecurity of this program found a weak spot when the program imports the standardized genome from government servers. The standardized genome sequence traveled over insecure channels, which created the opportunity for a common cyberattack called a "man-in-the-middle."

In this attack, an adversary or a hacker could intercept the standard genome sequence and then transmit it to a BWA user along with a malicious program that alters genetic information obtained from sequencing. The malware could then change a patient's raw genetic data during genome mapping, making the final analysis incorrect without anyone knowing it. Practically, this means doctors may prescribe a drug based on the genetic analysis that, had they had the correct information, they would have known would be ineffective or toxic to a patient.

Forensic labs and genome sequencing companies that also use this mapping software were also temporarily vulnerable to having results maliciously altered in the same way. Information from direct-to-consumer genetic tests was not affected by this vulnerability because these tests use a different sequencing method than whole genome sequencing, Hudson said.
I did not watch/listen to the 1 1/2 hour presentation about this project linked in this thread to find out what security measures are in place to keep this personal information private/safe during this whole process. But, I was wondering if you or someone else had reviewed either the 1 1/2 hour presentation or some other documentation from the NIH that addresses (in detail) the privacy/security concerns and measures in place to protect the storage, control and use of all of this personal medical/health information?
 
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Gemini

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@Gemini I was wondering if you or someone else had reviewed either the 1 1/2 hour presentation or some other documentation from the NIH that addresses (in detail) the privacy/security concerns and measures in place to protect the storage, control and use of all of this personal medical/health information?
@Wally, NIH indicated there will be future publications addressing the "Legal, Regulatory, Policy" workstream sector of this ELSI NIH Workshop so you might want to watch for them.

The June 24th Workshop summarized how and when "All Of Us" participant data will be collected and placed in the data repository, and how researchers can access it through a data access platform:

All Of Us Data Collection Protocol.JPG



All Of Us Researcher Workbench.JPG
 

Gemini

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Review article, New England Journal of Medicine, The "All Of Us" Research Program," August 15, 2019

Excerpts:

As of July 2019, the All of Us program had enrolled more than 175,000 core participants and more than 230,000 total participants; an additional 40,000 participants have registered on the website.

Among core participants, 51% are nonwhite and 80% meet our definition of being underrepresented in biomedical research; these percentages exceed the program goals.

A total of 34 health care provider organizations have uploaded EHR* data on more than 112,000 participants.

The recruitment rate, which is currently approximately 3100 core participants per week, is predictably increasing as new sites begin enrollment and existing sites mature.

We expect to have enrolled 1 million core participants by approximately 2024.

Since 2015, Congress has allocated $1.02 billion to the All of Us program; this includes funding for all current resources through 2019 as well as initial genome sequencing, initial bioassays, and establishment of a nationwide genetic counseling resource for participants to whom results are returned.

The 21st Century Cures Act authorized an additional $1.14 billion through 2026.

https://www.nejm.org/doi/full/10.1056/NEJMsr1809937

[my bold]
*EHR=Electronic Health Records
 

Gemini

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To reach rural, homebound, and others not near a Program site, in-home visiting services are planned.... The Fitbit company is participating; 3000 participants are currently providing their wearables data
Interestingly, the recent ME/CFS RFI asked for input from the public on how to include severe and homebound patients in research.

Someone suggested using the "All Of Us" Program and many others wearable devices.

Question: Is the ME/CFS research community looking at what"All Of Us" offers, anyone know?
@JaimeS @medfeb @jspotila
 
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