Evidence map›Paper›PMID 38943204›Full record

ArticleTrials2024

Comparative effectiveness of an individualized model of hemodialysis vs conventional hemodialysis: a study protocol for a multicenter randomized controlled trial (the TwoPlus trial).

Mariana Murea, Jochen G Raimann, Jasmin Divers, Harvey Maute, Cassandra Kovach, Emaad M Abdel-Rahman, Alaa S Awad, Jennifer E Flythe, Samir C Gautam, Vandana D Niyyar and 19 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05828823 (Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT05828823 narecruitingnot on this map

Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis

TypeinterventionalSponsorWake Forest University Health SciencesRan2024 to 2031Enrolled350ConditionsEnd-Stage Kidney DiseaseArmsHemodialysis twice weekly, Hemodialysis thrice weekly
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
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

29 authors.

Mariana MureaDepartment of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC, USA. mmurea@wakehealth.edu.
Jochen G RaimannRenal Research Institute, New York, NY, USA.ORCID http://orcid.org/0000-0002-8954-2783
Jasmin DiversDepartment of Foundations of Medicine, Center for Population and Health Services Research, NYU Grossman Long Island School of Medicine, New York, NY, USA.
Harvey MauteDepartment of Foundations of Medicine, Center for Population and Health Services Research, NYU Grossman Long Island School of Medicine, New York, NY, USA.
Cassandra KovachDepartment of Nephrology and Hypertension, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH, USA.
Emaad M Abdel-RahmanDivision of Nephrology, University of Virginia Health System, Charlottesville, VA, USA.
Alaa S AwadDivision of Nephrology, University of Florida, Jacksonville, FL, USA.
Jennifer E FlytheUniversity of North Carolina (UNC) Kidney Center, Division of Nephrology and Hypertension, Department of Medicine, UNC School of Medicine, Chapel Hill, NC, USA.
Samir C GautamDepartment of Medicine, Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Vandana D NiyyarDivision of Nephrology, Department of Medicine, Emory University, Atlanta, GA, USA.
Glenda V RobertsExternal Relations and Patient Engagement, Division of Nephrology, Department of Medicine, Kidney Research Institute and Center for Dialysis Innovation, University of Washington, Seattle, WA, USA.
Nichole M JeffersonHome Dialyzors United, Columbia, MO, USA.
Islam ShahidulDepartment of Foundations of Medicine, Center for Population and Health Services Research, NYU Grossman Long Island School of Medicine, New York, NY, USA.
Ucheoma NwaozuruDepartment of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Kristie L FoleyDepartment of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Erica J TrembathRenal Research Institute, New York, NY, USA.
Merlo L RosalesRenal Research Institute, New York, NY, USA.
Alison J FletcherDepartment of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC, USA.
Sheikh I HibaDepartment of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC, USA.
Anne HumlDepartment of Nephrology and Hypertension, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH, USA.
Daphne H KnicelyDivision of Nephrology, University of Virginia Health System, Charlottesville, VA, USA.
Irtiza HasanDivision of Nephrology, University of Florida, Jacksonville, FL, USA.
Bhaktidevi MakadiaDivision of Nephrology, University of Florida, Jacksonville, FL, USA.
Raman GauravDepartment of Medicine, Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Janice LeaDivision of Nephrology, Department of Medicine, Emory University, Atlanta, GA, USA.
Paul T ConwayAmerican Association of Kidney Patients, Tampa, FL, USA.
John T DaugirdasDivision of Nephrology, Department of Medicine, University of Illinois College of Medicine, Chicago, IL, USA.
Peter KotankoDepartment of Internal Medicine, Section on Nephrology, LLC Icahn School of Medicine at Mount Sinai, New York, NY, USA. Peter.Kotanko@rriny.com.
Two Plus Research Consortium

Funding

Patient-Centered Outcomes Research Institute CER-2022C1-26300
6 · The paper itself

Abstract

backgroundMost patients starting chronic in-center hemodialysis (HD) receive conventional hemodialysis (CHD) with three sessions per week targeting specific biochemical clearance. Observational studies suggest that patients with residual kidney function can safely be treated with incremental prescriptions of HD, starting with less frequent sessions and later adjusting to thrice-weekly HD. This trial aims to show objectively that clinically matched incremental HD (CMIHD) is non-inferior to CHD in eligible patients.

methodsAn unblinded, parallel-group, randomized controlled trial will be conducted across diverse healthcare systems and dialysis organizations in the USA. Adult patients initiating chronic hemodialysis (HD) at participating centers will be screened. Eligibility criteria include receipt of fewer than 18 treatments of HD and residual kidney function defined as kidney urea clearance ≥3.5 mL/min/1.73 m DISCUSSION: Our proposal challenges the status quo of HD care delivery. Our overarching hypothesis posits that CMIHD is non-inferior to CHD. If successful, the results will positively impact one of the highest-burdened patient populations and their caregivers.

trial registrationClinicaltrials.gov NCT05828823. Registered on 25 April 2023.

Indexed as

Multicenter Studies as TopicRenal DialysisComparative Effectiveness ResearchEquivalence Trials as TopicHumansKidney Failure, ChronicRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeUnited StatesEnd-stage kidney diseaseHemodialysisIncrementalRandomized controlled trial

Identifiers

PMID38943204
PMCPMC11212207

What OpenQuestion holds

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Registered trials

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.