Evidence map›Paper›PMID 41314824›Full record

ArticleBMJ open2025

Protocol for the process evaluation of a randomised clinical trial of incremental-start versus conventional haemodialysis: the TwoPlus study.

Mariana Murea, Kristie L Foley, Samir C Gautam, Jennifer E Flythe, Jochen G Raimann, Emaad Abdel-Rahman, Alaa S Awad, Vandana Dua Niyyar, Cassandra Kovach, Glenda V Roberts and 17 more

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

Article in BMJ open, 2025. 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

27 authors.

Mariana MureaDepartment of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.ORCID http://orcid.org/0000-0003-3217-1691
Kristie L FoleyDepartment of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Samir C GautamDepartment of Medicine, Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
Jennifer E FlytheUniversity of North Carolina Kidney Center, Division of Nephrology and Hypertension, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.
Jochen G RaimannRenal Research Institute, New York, New York, USA.
Emaad Abdel-RahmanDivision of Nephrology, University of Virginia Health System, Charlottesville, Virginia, USA.
Alaa S AwadDivision of Nephrology, University of Florida, Jacksonville, Florida, USA.
Vandana Dua NiyyarDepartment of Nephrology, Emory University School of Medicine, Atlanta, Georgia, USA.
Cassandra KovachDepartment of Kidney Medicine, Medical Specialties Institute, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, USA.
Glenda V RobertsExternal Relations and Patient Engagement, Kidney Research Institute and Center for Dialysis Innovation, Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington, USA.
Nicole M JeffersonHome Dialyzors United, Columbia, Missouri, USA.
Paul T ConwayAmerican Association of Kidney Patients, Tampa, Florida, USA.
Laura M RosalesRenal Research Institute, New York, New York, USA.
Jobira WoldemichaelDepartment of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Hiba I SheikhDepartment of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Gaurav RamanDepartment of Medicine, Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
Anne M HumlDepartment of Kidney Medicine, Medical Specialties Institute, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, USA.
Daphne H KnicelyDivision of Nephrology, University of Virginia Health System, Charlottesville, Virginia, USA.
Irtiza HasanDivision of Nephrology, University of Florida, Jacksonville, Florida, USA.
Bhaktidevi MakadiaDivision of Nephrology, University of Florida, Jacksonville, Florida, USA.
Janice LeaDepartment of Nephrology, Emory University School of Medicine, Atlanta, Georgia, USA.
John T DaugirdasDivision of Nephrology, Department of Medicine, University of Illinois College of Medicine at Chicago, Chicago, Illinois, USA.
Nihan GencerlilerDepartment of Foundations of Medicine, Division of Health Services Research, New York University Grossman School of Medicine, New York, New York, USA.
Jasmin DiversDepartment of Foundations of Medicine, Division of Health Services Research, New York University Grossman School of Medicine, New York, New York, USA.
Peter KotankoRenal Research Institute, New York, New York, USA.
TwoPlus Research Consortium
Ucheoma C NwaozuruDepartment of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA nwaozur2@gmail.com.ORCID http://orcid.org/0000-0002-0680-0928

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionProcess evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial. METHODS AND ANALYSIS: We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes' findings. ETHICS AND DISSEMINATION: The study protocol was approved by the Wake Forest University School of Medicine Institutional Review Board (IRB). Findings from this study will be disseminated through peer-reviewed journals and scientific conferences. TRIAL REGISTRATION NUMBER: NCT05828823.

Indexed as

Kidney Failure, ChronicProcess Assessment, Health CareRenal DialysisHumansRandomized Controlled Trials as TopicResearch DesignDialysisImplementation ScienceMethodsSurveys and Questionnaires

Identifiers

PMID41314824
PMCPMC12666213

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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 Socratic graph.