A Study for the Ages

A Study for the Ages In Richard K. Shields's McMillan Lecture,1 he exhorted physical therapists to take full advantage of the opportunities presented by the National Institutes of Health (NIH) All of Us cohort study. The mission of the All of Us research program is to advance the science of precision medicine and ensure that everyone shares in its benefits—with an ambitious goal of recruiting 1 million people from various backgrounds. Each enrollee will be followed prospectively for decades to provide researchers with environmental data, lifestyle data, and molecular biomarkers for metabolism, aging, and epigenetics. Shields noted that the All of Us research program has the potential to uncover important findings that can assist not only the mission of precision medicine but also the mission of physical therapy to optimize the precision of future movement interventions. He argued that physical therapists need to be involved with this innovative study and that people with disabilities need to be enrolled as participants so that we do not lose a unique research opportunity. Although I was aware of the All of Us study, I had little knowledge of any of the study details until Shields's McMillan Lecture prompted me to look more deeply into this NIH initiative. I discovered several features of the study and opportunities that may be of interest to the readers of PTJ. First, the overall objective of the All of Us Research Program, as articulated by the study director, Dr Eric Dishman, is to build an observational research resource that will provide the information needed to address a wide range of scientific questions, facilitating the exploration of biological, clinical, social, and environmental determinants of health and disease.2 The program will collect and curate health-related data and biospecimens from 1 million or more individuals who reflect the diversity of the United States; these data and biospecimens will be made broadly available for research uses. Dishman has noted that this national resource may help researchers better understand the complexities of how such factors as biology, genetics, location, behavior, social life, exposure, and environment interact to influence health at both a population and individual level.2 The All of Us Research Program recently released its initial protocol, which is for participants aged 18 years and older. As described in the protocol, participants will be invited to share their electronic health records (EHRs), if any, and answer health-related questionnaires. Some participants also may be invited to undergo physical measurements and provide biospecimens from which genomic information and other biomarkers may be derived through analytics. The DNA, for example, will be sequenced when samples and funds are available and will be linked with behavioral and environmental data and the data in the EHR. Qualified researchers from many organizations will, with appropriate protection of participant confidentiality, have access to the cohort's deidentified data for future research and analysis.3 Based on the materials provided by the NIH, it appears that the research protocols are still in the initial stages and are currently undergoing beta testing and that investigators have started recruiting participants. The program started small with enrollment and is scaling up carefully, beginning with 1 site and gradually expanding to more than 100 sites nationally during the beta phase. All of Us beta study partners began testing in Fall 2017, hoping to eventually enroll at least 10,000 people across the United States. This beta test will help investigators identify problems with their systems and protocols and will help them evaluate and improve recruitment approaches with diverse communities across the country. Diversity is central to All of Us program planning, and Dishman hopes that over time, the data will represent the most diverse collection of people in human history.2,4 Although the initial version of the research protocol has been developed, many of the study plans are still in development, and investigators will update the protocol as things progress. Future versions will include additional surveys, broader eligibility criteria, plans for genomic and other laboratory tests of participants’ blood and urine samples, plans to pilot-test wearable devices for real-time data collection, and more details about data access policies.3 Importantly, the opportunity still exists for physical therapists and other rehabilitation professionals to have input into the final All of Us research protocols. Study investigators are working with partners across their consortium, including a Precision Medicine Initiative Working Group of the Advisory Committee to the Director and the All of Us Research Program Advisory Panel. The names of the individuals serving on these advisory committees are publicly available, and I urge the rehabilitation community to reach out to individual members of these advisory bodies to share with them valuable input on critical rehabilitation-related research questions that could be asked in the All of Us protocols to help develop future precision movement interventions. For example, is detailed information going to be collected on participants’ level of physical activity and level of functioning? What elements of the environment will be included? And, if so, how will these areas be assessed? After completion of the All of Us beta phase, anyone over the age of 18 years who is living in the United States will be able to join the All of Us study, either directly through the JoinAllofUs.org website or through participating health care provider organizations.5 Ultimately, All of Us wants to build a community at least 1 million strong, with participants from all walks of life and all parts of the country. Historically, prospective cohort studies have had great difficulty enrolling participants with disabilities; consequently, this cohort has been underrepresented in most previous cohort studies. The All of Us investigators have explicitly identified diversity of participants as a study goal, and, as Shields highlighted for us, enrolling people with a disability will be critical if the ambitious goals of the All of Us study are to be realized. Rehabilitation professionals can assist All of Us investigators in developing recruitment methods to help them reach this population. Individuals interested in joining the All of Us research study will be able to enroll through participating health care provider organizations (HPOs) or directly through the Participant Technologies Center.5 The HPO network will include regional and national medical centers, community health centers, and medical centers operated by the US Department of Veterans Affairs. This broad network is designed to ensure that participants in the research represent the geographic, ethnic, racial, and socioeconomic diversity of the country. A list of the numerous organizations selected as the initial set of HPOs is available.5 These HPOs will engage their patients in All of Us, help build the research protocols and plans, enroll interested individuals, and collect essential health data and biological specimens. Finally, the All of Us data will eventually become a publicly accessible resource available to researchers of all kinds, from citizen scientists to investigators in academia and industry, for studies on a variety of health topics.6 A biobank, managed by the Mayo Clinic, will handle the collection, analyses, storage, and distribution of biospecimens for research use. Data from laboratory analyses of the biospecimens will be integrated with information from participants’ records, including lifestyle and clinical records. Access to the data will be managed through the program's data and research support center, which is expected to build an active community of researchers who can learn from the information and propose new research initiatives. Vanderbilt University Medical Center, working with the Broad Institute and Verily, won the primary award for this data and research support center program. Additional funding is going to Columbia University Medical Center, Northwestern University Feinberg School of Medicine, University of Michigan School of Public Health, and the University of Texas Health Science Center at Houston School of Biomedical Informatics. I urge readers to reach out to the investigators. The goal of the All of Us initiative as originally designed holds great promise to solve some of the most challenging riddles of medicine. If rehabilitation professionals make the most of this opportunity, the All of Us study can become a major research resource for rehabilitation researchers for years to come. References 1 Shields R. Turning over the hourglass. Forty-Eighth Mary McMillan Lecture. Phys Ther . 2017; 97: 949– 963. Google Scholar PubMed  2 Venditto G. NIH “ All of Us” precision medicine program gears up to launch. Mobile Health News website. http://www.mobihealthnews.com/content/nih-all-us-precision-medicine-program-gears-launch. Published May 17, 2017. Accessed October 30, 2017. 3 The All of Us Research Program initial protocol. National Institutes of Health All of us Research Program website. https://allofus.nih.gov/news-events-and-media/announcements/all-us-research-program-initial-protocol. Published August 4, 2017. Accessed October 30, 2017. 4 About the All of Us research program. https://allofus.nih.gov/about/about-all-us-research-program. National Institutes of Health All of us Research Program website. Accessed October 30, 2017. 5 Health care provider organizations. National Institutes of Health All of Us Research Program website. https://allofus.nih.gov/about/program-components/health-care-provider-organizations. Accessed October 30, 2017. 6 Beta Testing begins for NIH’s All of Us Research Program. National Institutes of Health website. https://allofus.nih.gov/news-events-and-media/announcements/beta-testing-begins-nihs-all-us-research-program Published June 5, 2017. Accessed October 30, 2017. © 2018 American Physical Therapy Association http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Physical Therapy Oxford University Press

A Study for the Ages

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Publisher
American Physical Therapy Association
Copyright
© 2018 American Physical Therapy Association
ISSN
0031-9023
eISSN
1538-6724
D.O.I.
10.1093/ptj/pzx114
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Abstract

In Richard K. Shields's McMillan Lecture,1 he exhorted physical therapists to take full advantage of the opportunities presented by the National Institutes of Health (NIH) All of Us cohort study. The mission of the All of Us research program is to advance the science of precision medicine and ensure that everyone shares in its benefits—with an ambitious goal of recruiting 1 million people from various backgrounds. Each enrollee will be followed prospectively for decades to provide researchers with environmental data, lifestyle data, and molecular biomarkers for metabolism, aging, and epigenetics. Shields noted that the All of Us research program has the potential to uncover important findings that can assist not only the mission of precision medicine but also the mission of physical therapy to optimize the precision of future movement interventions. He argued that physical therapists need to be involved with this innovative study and that people with disabilities need to be enrolled as participants so that we do not lose a unique research opportunity. Although I was aware of the All of Us study, I had little knowledge of any of the study details until Shields's McMillan Lecture prompted me to look more deeply into this NIH initiative. I discovered several features of the study and opportunities that may be of interest to the readers of PTJ. First, the overall objective of the All of Us Research Program, as articulated by the study director, Dr Eric Dishman, is to build an observational research resource that will provide the information needed to address a wide range of scientific questions, facilitating the exploration of biological, clinical, social, and environmental determinants of health and disease.2 The program will collect and curate health-related data and biospecimens from 1 million or more individuals who reflect the diversity of the United States; these data and biospecimens will be made broadly available for research uses. Dishman has noted that this national resource may help researchers better understand the complexities of how such factors as biology, genetics, location, behavior, social life, exposure, and environment interact to influence health at both a population and individual level.2 The All of Us Research Program recently released its initial protocol, which is for participants aged 18 years and older. As described in the protocol, participants will be invited to share their electronic health records (EHRs), if any, and answer health-related questionnaires. Some participants also may be invited to undergo physical measurements and provide biospecimens from which genomic information and other biomarkers may be derived through analytics. The DNA, for example, will be sequenced when samples and funds are available and will be linked with behavioral and environmental data and the data in the EHR. Qualified researchers from many organizations will, with appropriate protection of participant confidentiality, have access to the cohort's deidentified data for future research and analysis.3 Based on the materials provided by the NIH, it appears that the research protocols are still in the initial stages and are currently undergoing beta testing and that investigators have started recruiting participants. The program started small with enrollment and is scaling up carefully, beginning with 1 site and gradually expanding to more than 100 sites nationally during the beta phase. All of Us beta study partners began testing in Fall 2017, hoping to eventually enroll at least 10,000 people across the United States. This beta test will help investigators identify problems with their systems and protocols and will help them evaluate and improve recruitment approaches with diverse communities across the country. Diversity is central to All of Us program planning, and Dishman hopes that over time, the data will represent the most diverse collection of people in human history.2,4 Although the initial version of the research protocol has been developed, many of the study plans are still in development, and investigators will update the protocol as things progress. Future versions will include additional surveys, broader eligibility criteria, plans for genomic and other laboratory tests of participants’ blood and urine samples, plans to pilot-test wearable devices for real-time data collection, and more details about data access policies.3 Importantly, the opportunity still exists for physical therapists and other rehabilitation professionals to have input into the final All of Us research protocols. Study investigators are working with partners across their consortium, including a Precision Medicine Initiative Working Group of the Advisory Committee to the Director and the All of Us Research Program Advisory Panel. The names of the individuals serving on these advisory committees are publicly available, and I urge the rehabilitation community to reach out to individual members of these advisory bodies to share with them valuable input on critical rehabilitation-related research questions that could be asked in the All of Us protocols to help develop future precision movement interventions. For example, is detailed information going to be collected on participants’ level of physical activity and level of functioning? What elements of the environment will be included? And, if so, how will these areas be assessed? After completion of the All of Us beta phase, anyone over the age of 18 years who is living in the United States will be able to join the All of Us study, either directly through the JoinAllofUs.org website or through participating health care provider organizations.5 Ultimately, All of Us wants to build a community at least 1 million strong, with participants from all walks of life and all parts of the country. Historically, prospective cohort studies have had great difficulty enrolling participants with disabilities; consequently, this cohort has been underrepresented in most previous cohort studies. The All of Us investigators have explicitly identified diversity of participants as a study goal, and, as Shields highlighted for us, enrolling people with a disability will be critical if the ambitious goals of the All of Us study are to be realized. Rehabilitation professionals can assist All of Us investigators in developing recruitment methods to help them reach this population. Individuals interested in joining the All of Us research study will be able to enroll through participating health care provider organizations (HPOs) or directly through the Participant Technologies Center.5 The HPO network will include regional and national medical centers, community health centers, and medical centers operated by the US Department of Veterans Affairs. This broad network is designed to ensure that participants in the research represent the geographic, ethnic, racial, and socioeconomic diversity of the country. A list of the numerous organizations selected as the initial set of HPOs is available.5 These HPOs will engage their patients in All of Us, help build the research protocols and plans, enroll interested individuals, and collect essential health data and biological specimens. Finally, the All of Us data will eventually become a publicly accessible resource available to researchers of all kinds, from citizen scientists to investigators in academia and industry, for studies on a variety of health topics.6 A biobank, managed by the Mayo Clinic, will handle the collection, analyses, storage, and distribution of biospecimens for research use. Data from laboratory analyses of the biospecimens will be integrated with information from participants’ records, including lifestyle and clinical records. Access to the data will be managed through the program's data and research support center, which is expected to build an active community of researchers who can learn from the information and propose new research initiatives. Vanderbilt University Medical Center, working with the Broad Institute and Verily, won the primary award for this data and research support center program. Additional funding is going to Columbia University Medical Center, Northwestern University Feinberg School of Medicine, University of Michigan School of Public Health, and the University of Texas Health Science Center at Houston School of Biomedical Informatics. I urge readers to reach out to the investigators. The goal of the All of Us initiative as originally designed holds great promise to solve some of the most challenging riddles of medicine. If rehabilitation professionals make the most of this opportunity, the All of Us study can become a major research resource for rehabilitation researchers for years to come. References 1 Shields R. Turning over the hourglass. Forty-Eighth Mary McMillan Lecture. Phys Ther . 2017; 97: 949– 963. Google Scholar PubMed  2 Venditto G. NIH “ All of Us” precision medicine program gears up to launch. Mobile Health News website. http://www.mobihealthnews.com/content/nih-all-us-precision-medicine-program-gears-launch. Published May 17, 2017. Accessed October 30, 2017. 3 The All of Us Research Program initial protocol. National Institutes of Health All of us Research Program website. https://allofus.nih.gov/news-events-and-media/announcements/all-us-research-program-initial-protocol. Published August 4, 2017. Accessed October 30, 2017. 4 About the All of Us research program. https://allofus.nih.gov/about/about-all-us-research-program. National Institutes of Health All of us Research Program website. Accessed October 30, 2017. 5 Health care provider organizations. National Institutes of Health All of Us Research Program website. https://allofus.nih.gov/about/program-components/health-care-provider-organizations. Accessed October 30, 2017. 6 Beta Testing begins for NIH’s All of Us Research Program. National Institutes of Health website. https://allofus.nih.gov/news-events-and-media/announcements/beta-testing-begins-nihs-all-us-research-program Published June 5, 2017. Accessed October 30, 2017. © 2018 American Physical Therapy Association

Journal

Physical TherapyOxford University Press

Published: Feb 1, 2018

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