TY - JOUR
T1 - Pragmatic trials in maintenance dialysis
T2 - Perspectives from the kidney health initiative
AU - Dember, Laura M.
AU - Archdeacon, Patrick
AU - Krishnan, Mahesh
AU - Lacson, Eduardo
AU - Ling, Shari M.
AU - Roy-Chaudhury, Prabir
AU - Smith, Kimberly A.
AU - Flessner, Michael F.
N1 - Funding Information:
KHI makes every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of industry relationships or personal interests among the members of the workgroup. More information on KHI, the workgroup, or the conflict of interest policy can be found at www. kidneyhealthinitiative.org. The TiME Trial is funded by the National Institutes of Health Office of the Director and the National Institute of Diabetes and Digestive and Kidney Diseases (UH2-AT007797 and UH3-DK102384 to L.M.D.). The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of any agency of the US Government, DaVita Healthcare Partners, or Fresenius Medical Care.
Funding Information:
This work was supported by the Kidney Health Initiative (KHI), a public-private partnership between the American Society of Nephrology, the US Food and Drug Administration, and .75 member organizations and companies to enhance patient safety and foster innovation in kidney disease. KHI funds were used to defray costs incurred during the conduct of the project, including project management support which was expertly provided by American Society of Nephrology staff members, Melissa West and Ryan Murray. There was no honorarium or other financial support provided to KHI workgroup members. The authors of this paper had final review authority and are fully responsible for its content.
Publisher Copyright:
Copyright © 2016 by the American Society of Nephrology.
PY - 2016
Y1 - 2016
N2 - Pragmatic clinical trials are conducted under the real-world conditions of clinical care delivery. As a result, these trials yield findings that are highly generalizable to the nonresearch setting, identify interventions that are readily translatable into clinical practice, and cost less than trials that require extensive research infrastructures. Maintenance dialysis is a setting especially well suited for pragmatic trials because of inherently frequent and predictable patient encounters, highly granular and uniform data collection, use of electronic data systems, and delivery of care by a small number of provider organizations to approximately 90%of patients nationally. Recognizing the potential for pragmatic trials to generatemuch needed evidence to guide the care of patients receiving maintenance dialysis, the Kidney Health Initiative assembled a group of individuals with relevant expertise from academia, industry, and government to provide the nephrology community with information about the design and conduct of such trials, with a specific focus on the dialysis setting. Here, we review this information, and where applicable, use experience fromthe ongoing Time to Reduce Mortality in End Stage Renal Disease Trial, a large cluster-randomized, pragmatic trial evaluating hemodialysis session duration, to illustrate challenges and solutions to operational, ethical, and regulatory issues.
AB - Pragmatic clinical trials are conducted under the real-world conditions of clinical care delivery. As a result, these trials yield findings that are highly generalizable to the nonresearch setting, identify interventions that are readily translatable into clinical practice, and cost less than trials that require extensive research infrastructures. Maintenance dialysis is a setting especially well suited for pragmatic trials because of inherently frequent and predictable patient encounters, highly granular and uniform data collection, use of electronic data systems, and delivery of care by a small number of provider organizations to approximately 90%of patients nationally. Recognizing the potential for pragmatic trials to generatemuch needed evidence to guide the care of patients receiving maintenance dialysis, the Kidney Health Initiative assembled a group of individuals with relevant expertise from academia, industry, and government to provide the nephrology community with information about the design and conduct of such trials, with a specific focus on the dialysis setting. Here, we review this information, and where applicable, use experience fromthe ongoing Time to Reduce Mortality in End Stage Renal Disease Trial, a large cluster-randomized, pragmatic trial evaluating hemodialysis session duration, to illustrate challenges and solutions to operational, ethical, and regulatory issues.
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U2 - 10.1681/ASN.2016030340
DO - 10.1681/ASN.2016030340
M3 - Review article
C2 - 27401689
AN - SCOPUS:85018957819
VL - 27
SP - 2955
EP - 2963
JO - Journal of the American Society of Nephrology : JASN
JF - Journal of the American Society of Nephrology : JASN
SN - 1046-6673
IS - 10
ER -