TY - JOUR
T1 - Justice and equity in pragmatic clinical trials
T2 - Considerations for pain research within integrated health systems
AU - Ali, Joseph
AU - Davis, Alison F.
AU - Burgess, Diana J.
AU - Rhon, Daniel I.
AU - Vining, Robert
AU - Young-McCaughan, Stacey
AU - Green, Sean
AU - Kerns, Robert D.
N1 - Funding Information:
Research reported in this publication was made possible by Award No. U24 AT009769 from NCCIH and OBSSR. In addition, some authors were individually supported by NCCIH under awards AT009763 and AT009767; and the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, through the Pain Management Collaboratory‐Pragmatic Clinical Trials Demonstration Projects under awards W81XWH‐18‐2‐0003 and W81XWH‐18‐2‐0008.
Funding Information:
Research reported in this publication was made possible by Award No. U24 AT009769 from the U.S. National Institutes of Health (NIH) National Center for Complementary and Integrative Health (NCCIH) and the NIH Office of Behavioral and Social Sciences Research (OBSSR). In addition, some authors were individually supported by NCCIH under awards AT009763 and AT009767; and the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, through the Pain Management Collaboratory‐Pragmatic Clinical Trials Demonstration Projects under awards W81XWH‐18‐2‐0003 and W81XWH‐18‐2‐0008 Funding information
Funding Information:
The NIH‐DOD‐VA Pain Management Collaboratory operates a Coordinating Center that is supported by the U.S. National Institutes of Health (NIH) National Center for Complementary and Integrative Health (NCCIH) and the NIH Office of Behavioral and Social Sciences Research (OBSSR). Projects are individually supported by multiple U.S. government agencies and entities, including NIH (NCCIH, National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Drug Abuse (NIDA), National Institute of Alcohol Abuse and Alcoholism (NIAAA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Research on Women's Health (ORWH), and National Institute of Nursing Research (NINR)); Department of Defense (DOD) (Clinical and Rehabilitative Medicine Research Program (CRMRP), Military Operational Medicine Research Program (MOMRP)); the Uniformed Services University of the Health Sciences (USU); and Department of Veterans Affairs (VA) Health Services Research & Development (HSR&D) Service of the Office of Research and Development.
Funding Information:
The NIH-DOD-VA Pain Management Collaboratory operates a Coordinating Center that is supported by the U.S. National Institutes of Health (NIH) National Center for Complementary and Integrative Health (NCCIH) and the NIH Office of Behavioral and Social Sciences Research (OBSSR). Projects are individually supported by multiple U.S. government agencies and entities, including NIH (NCCIH, National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Drug Abuse (NIDA), National Institute of Alcohol Abuse and Alcoholism (NIAAA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Research on Women's Health (ORWH), and National Institute of Nursing Research (NINR)); Department of Defense (DOD) (Clinical and Rehabilitative Medicine Research Program (CRMRP), Military Operational Medicine Research Program (MOMRP)); the Uniformed Services University of the Health Sciences (USU); and Department of Veterans Affairs (VA) Health Services Research & Development (HSR&D) Service of the Office of Research and Development. Research reported in this publication was made possible by Award No. U24 AT009769 from NCCIH and OBSSR. In addition, some authors were individually supported by NCCIH under awards AT009763 and AT009767; and the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, through the Pain Management Collaboratory-Pragmatic Clinical Trials Demonstration Projects under awards W81XWH-18-2-0003 and W81XWH-18-2-0008. The content of this publication is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, the Department of Defense, the U.S. Department of Veterans Affairs or the United States Government. For more information about the NIH-DOD-VA Pain Management Collaboratory, visit https://painmanagementcollaboratory.org/.
Publisher Copyright:
© 2021 The Authors. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan.
PY - 2021
Y1 - 2021
N2 - Introduction: Pragmatic clinical trials (PCTs) can overcome implementation challenges for bringing evidence-based therapies to people living with pain and co-occurring conditions, providing actionable information for patients, providers, health systems, and policy makers. All studies, including those conducted within health systems that have a history of advancing equitable care, should make efforts to address justice and equity. Methods: Drawing from collective experience within pragmatic pain clinical trials networks, and synthesizing relevant literature, our multidisciplinary working group examined challenges related to integrating justice and equity into pragmatic pain management research conducted in large, integrated health systems. Our analysis draws from military and veteran health system contexts but offers strategies to consider throughout the lifecycle of pragmatic research more widely. Results: We found that PCTs present a unique opportunity to address major influences on health inequities by occupying a space between research, healthcare delivery, and the complexities of everyday life. We highlight key challenges that require attention to support complementary advancement of justice and equity via pragmatic research, offering several strategies that can be pursued. Conclusions: Efforts are needed to engage diverse stakeholders broadly and creatively in PCTs, such as through dedicated health equity working groups and other collaborative relationships with stakeholders, to support robust and inclusive approaches to research design and implementation across study settings. These considerations, while essential to pain management research, offer important opportunities toward achieving more equitable healthcare and health systems to benefit people living with pain and co-occurring conditions.
AB - Introduction: Pragmatic clinical trials (PCTs) can overcome implementation challenges for bringing evidence-based therapies to people living with pain and co-occurring conditions, providing actionable information for patients, providers, health systems, and policy makers. All studies, including those conducted within health systems that have a history of advancing equitable care, should make efforts to address justice and equity. Methods: Drawing from collective experience within pragmatic pain clinical trials networks, and synthesizing relevant literature, our multidisciplinary working group examined challenges related to integrating justice and equity into pragmatic pain management research conducted in large, integrated health systems. Our analysis draws from military and veteran health system contexts but offers strategies to consider throughout the lifecycle of pragmatic research more widely. Results: We found that PCTs present a unique opportunity to address major influences on health inequities by occupying a space between research, healthcare delivery, and the complexities of everyday life. We highlight key challenges that require attention to support complementary advancement of justice and equity via pragmatic research, offering several strategies that can be pursued. Conclusions: Efforts are needed to engage diverse stakeholders broadly and creatively in PCTs, such as through dedicated health equity working groups and other collaborative relationships with stakeholders, to support robust and inclusive approaches to research design and implementation across study settings. These considerations, while essential to pain management research, offer important opportunities toward achieving more equitable healthcare and health systems to benefit people living with pain and co-occurring conditions.
KW - equity
KW - ethics
KW - justice
KW - pain management
KW - pragmatic clinical trial
UR - http://www.scopus.com/inward/record.url?scp=85117194369&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85117194369&partnerID=8YFLogxK
U2 - 10.1002/lrh2.10291
DO - 10.1002/lrh2.10291
M3 - Article
AN - SCOPUS:85117194369
JO - Learning Health Systems
JF - Learning Health Systems
SN - 2379-6146
ER -