Evidence map›Paper›PMID 27401689›Full record

ReviewJournal of the American Society of Nephrology : JASN2016

Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative.

Laura M Dember, Patrick Archdeacon, Mahesh Krishnan, Eduardo Lacson, Shari M Ling, Prabir Roy-Chaudhury, Kimberly A Smith, Michael F Flessner

Open access · greenAbstract readReview
In one paragraph

Review in Journal of the American Society of Nephrology : JASN, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
5.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 37 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Design and Rationale of HiLo: A Pragmatic, Randomized Trial of Phosphate Management for Patients Receiving Maintenance Hemodialysis.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2021
    Article
  6. Article
  7. The current and future landscape of dialysis.Nature reviews. Nephrology · 2020
    Review
  8. Review
  9. Article
  10. Ethical Issues in Pragmatic Cluster-Randomized Trials in Dialysis Facilities.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2019
    Review
  11. Article
  12. Review
  13. A Pragmatic Step Forward: AKI and Beyond.Journal of the American Society of Nephrology : JASN · 2019
    Article
  14. Article
  15. Article
  16. Perspectives on Research Participation and Facilitation Among Dialysis Patients, Clinic Personnel, and Medical Providers: A Focus Group Study.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2018
    Article
  17. Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 7 institutions in 1 country.

Laura M DemberRenal, Electrolyte and Hypertension Division and Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; ldember@upenn.edu.
Patrick ArchdeaconOffice of Medical Policy and Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Mahesh KrishnanDaVita Healthcare Partners, Denver, Colorado.
Eduardo LacsonNephrology Division, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts.
Shari M LingCenter for Clinical Standards and Quality, Centers for Medicare and Medicaid Services, Baltimore, Maryland.
Prabir Roy-ChaudhuryDivision of Nephrology, The University of Arizona College of Medicine and Southern Arizona Veterans Administration Health Care System, Tucson, Arizona.
Kimberly A SmithCenter for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Michael F FlessnerDivision of Kidney, Urology, and Hematology, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland.
Center for Drug Evaluation and Research · USCenters for Medicare and Medicaid Services · USNational Institute of Diabetes and Digestive and Kidney Diseases · USTufts Medical Center · USUnited States Food and Drug Administration · USUniversity of Arizona · USUniversity of Pennsylvania · US

Funding

Pragmatic Trials in Maintenance HemodialysisUH3DK102384 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI DEMBER, LAURA M · 2013 to 2016
$5.8M
Pragmatic Trials in Maintenance HemodialysisUH2AT007797 · NCCIH · UNIVERSITY OF PENNSYLVANIA · PI DEMBER, LAURA M · 2012 to 2012
$851k
NCCIH NIH HHS UH2 AT007797NIDDK NIH HHS UH3 DK102384
6 · The paper itself

Abstract

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 generate much 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 from the 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.

Indexed as

Pragmatic Clinical Trials as TopicRenal DialysisBiomedical ResearchHumansRenal Insufficiency, Chroniccluster randomizationelectronic medical recordethical and regulatory issueshealth systemsinformed consent

Identifiers

PMID27401689
PMCPMC5042681
OpenAlexW2460727135

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.